Trilogy®
274 catalogue numbers from 6110-44-22, listed by Zimmer, Inc., United States, under Sterilizer, Chemical. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
274catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (1), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ningbo Incote Precision Machinery Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 2 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
Record
| Listed by | Zimmer, Inc., United States |
|---|---|
| FDA product code | MLR |
| Device type | Sterilizer, Chemical |
| Device class | Class 2 |
| Regulation | 21 CFR 880.6860 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K934765 |
| Record published | 2015-09-24 |
| Record revised | 2019-08-16 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Sizes | Lumen/inner diameter 22 to 32 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6110-44-22 | 10 Deg. Elevated Rim | In distribution |
| 6120-64-26 | 20 Deg. Elevated Rim | In distribution |
| 6105-62-22 | Lumen/Inner Diameter 22 mm | In distribution |
| 6141-60-22 | Lumen/Inner Diameter 22 mm | In distribution |
| 6120-80-22 | 20 Deg. Elevated Rim | In distribution |
| 6141-50-32 | Lumen/Inner Diameter 32 mm | In distribution |
| 6141-62-28 | 7 mm Offset | In distribution |
| 6141-64-26 | Lumen/Inner Diameter 26.00 mm | In distribution |
| 6120-66-28 | 20 Deg. Elevated Rim | In distribution |
| 6105-70-32 | Lumen/Inner Diameter 32.00 mm | In distribution |
| 6141-64-32 | Lumen/Inner Diameter 32.00 mm | In distribution |
| 6120-74-28 | 20 Deg. Elevated Rim | In distribution |
| 6105-78-32 | Lumen/Inner Diameter 32.00 mm | In distribution |
| 6105-66-22 | Lumen/Inner Diameter 22.00 mm | In distribution |
| 6105-70-28 | Lumen/Inner Diameter 28 mm | In distribution |
| 6105-64-32 | Lumen/Inner Diameter 32 mm | In distribution |
| 6141-66-28 | 7 mm Offset | In distribution |
| 6110-50-26 | Lumen/Inner Diameter 26.00 mm | In distribution |
| 6120-46-22 | 20 Deg. Elevated Rim | In distribution |
| 6110-72-32 | 10 Deg. Elevated Rim | In distribution |
| 6105-74-26 | Lumen/Inner Diameter 26 mm | In distribution |
| 6120-50-32 | 20 Deg. Elevated Rim | In distribution |
| 6120-76-28 | Lumen/Inner Diameter 28 mm | In distribution |
| 6110-38-22 | Lumen/Inner Diameter 22 mm | In distribution |
| 6141-44-22 | Lumen/Inner Diameter 22 mm | In distribution |
| 6120-58-28 | Lumen/Inner Diameter 28.00 mm | In distribution |
| 6105-46-26 | Lumen/Inner Diameter 26.00 mm | In distribution |
| 6105-44-28 | Lumen/Inner Diameter 28 mm | In distribution |
| 6105-60-26 | Lumen/Inner Diameter 26 mm | In distribution |
| 6110-50-32 | 10 Deg. Elevated Rim | In distribution |
| 6141-42-22 | 7 mm Offset | In distribution |
| 6141-66-22 | 7 mm Offset | In distribution |
| 6110-48-22 | 10 Deg. Elevated Rim | In distribution |
| 6110-44-26 | Lumen/Inner Diameter 26 mm | In distribution |
| 6110-64-32 | 10 Deg. Elevated Rim | In distribution |
| 6110-68-22 | Lumen/Inner Diameter 22 mm | In distribution |
| 6105-78-28 | Lumen/Inner Diameter 28 mm | In distribution |
| 6110-40-22 | 10 Deg. Elevated Rim | In distribution |
| 6141-62-26 | Lumen/Inner Diameter 26.00 mm | In distribution |
| 6105-72-26 | Lumen/Inner Diameter 26.00 mm | In distribution |
| 6105-74-32 | Lumen/Inner Diameter 32 mm | In distribution |
| 6141-58-26 | 7 mm Offset | In distribution |
| 6120-60-22 | 20 Deg. Elevated Rim | In distribution |
| 6120-50-28 | 20 Deg. Elevated Rim | In distribution |
| 6141-70-32 | Lumen/Inner Diameter 32.00 mm | In distribution |
| 6141-48-28 | 7 mm Offset | In distribution |
| 6141-46-22 | 7 mm Offset | In distribution |
| 6141-56-22 | 7 mm Offset | In distribution |
| 6120-50-26 | Lumen/Inner Diameter 26 mm | In distribution |
| 6141-56-32 | 7 mm Offset | In distribution |
| 6141-70-32 | 7 mm Offset | In distribution |
| 6120-42-26 | Lumen/Inner Diameter 26 mm | In distribution |
| 6105-36-22 | Lumen/Inner Diameter 22.00 mm | In distribution |
| 6110-46-26 | 10 Deg. Elevated Rim | In distribution |
| 6110-58-28 | 10 Deg. Elevated Rim | In distribution |
| 6110-66-22 | Lumen/Inner Diameter 22 mm | In distribution |
| 6105-60-22 | Lumen/Inner Diameter 22 mm | In distribution |
| 6120-68-26 | Lumen/Inner Diameter 26 mm | In distribution |
| 6105-68-22 | Lumen/Inner Diameter 22 mm | In distribution |
| 6141-56-22 | 7 mm Offset | In distribution |
| 6110-56-26 | 10 Deg. Elevated Rim | In distribution |
| 6105-62-32 | Lumen/Inner Diameter 32 mm | In distribution |
| 6105-64-26 | Lumen/Inner Diameter 26 mm | In distribution |
| 6120-44-22 | Lumen/Inner Diameter 22.00 mm | In distribution |
| 6110-70-28 | Lumen/Inner Diameter 28 mm | In distribution |
| 6105-70-28 | Lumen/Inner Diameter 28.00 mm | In distribution |
| 6105-70-22 | Lumen/Inner Diameter 22.00 mm | In distribution |
| 6110-64-28 | 10 Deg. Elevated Rim | In distribution |
| 6110-46-26 | 10 Deg. Elevated Rim | In distribution |
| 6120-66-22 | Lumen/Inner Diameter 22 mm | In distribution |
| 6141-42-22 | Lumen/Inner Diameter 22.00 mm | In distribution |
| 6141-68-28 | Lumen/Inner Diameter 28.00 mm | In distribution |
| 6120-62-32 | 20 Deg. Elevated Rim | In distribution |
| 6141-68-32 | Lumen/Inner Diameter 32 mm | In distribution |
| 6110-76-22 | Lumen/Inner Diameter 22 mm | In distribution |
| 6110-62-28 | 10 Deg. Elevated Rim | In distribution |
| 6120-46-26 | 20 Deg. Elevated Rim | In distribution |
| 6105-72-32 | Lumen/Inner Diameter 32.00 mm | In distribution |
| 6120-48-22 | Lumen/Inner Diameter 22 mm | In distribution |
| 6120-56-32 | Lumen/Inner Diameter 32.00 mm | In distribution |
| 6105-50-28 | Lumen/Inner Diameter 28 mm | In distribution |
| 6105-50-26 | Lumen/Inner Diameter 26 mm | In distribution |
| 6120-48-26 | 20 Deg. Elevated Rim | In distribution |
| 6105-48-22 | Lumen/Inner Diameter 22.00 mm | In distribution |
| 6110-78-28 | Lumen/Inner Diameter 28 mm | In distribution |
| 6110-62-26 | Lumen/Inner Diameter 26.00 mm | In distribution |
| 6110-68-28 | Lumen/Inner Diameter 28 mm | In distribution |
| 6105-80-26 | Lumen/Inner Diameter 26 mm | In distribution |
| 6110-72-32 | 10 Deg. Elevated Rim | In distribution |
| 6110-50-28 | 10 Deg. Elevated Rim | In distribution |
| 6105-48-26 | Lumen/Inner Diameter 26 mm | In distribution |
| 6120-72-32 | 20 Deg. Elevated Rim | In distribution |
| 6105-76-22 | Lumen/Inner Diameter 22 mm | In distribution |
| 6105-78-32 | Lumen/Inner Diameter 32 mm | In distribution |
| 6120-80-26 | Lumen/Inner Diameter 26 mm | In distribution |
| 6141-60-28 | 7 mm Offset | In distribution |
| 6105-62-26 | Lumen/Inner Diameter 26 mm | In distribution |
| 6141-58-32 | 7 mm Offset | In distribution |
| 6141-50-28 | Lumen/Inner Diameter 28.00 mm | In distribution |
| 6105-46-28 | Lumen/Inner Diameter 28 mm | In distribution |
| 6105-46-28 | Lumen/Inner Diameter 28.00 mm | In distribution |
| 6105-42-26 | Lumen/Inner Diameter 26.00 mm | In distribution |
| 6120-72-26 | Lumen/Inner Diameter 26.00 mm | In distribution |
| 6120-60-32 | Lumen/Inner Diameter 32.00 mm | In distribution |
| 6141-50-32 | 7 mm Offset | In distribution |
| 6110-62-22 | 10 Deg. Elevated Rim | In distribution |
| 6110-78-26 | Lumen/Inner Diameter 26 mm | In distribution |
| 6120-42-26 | 20 Deg. Elevated Rim | In distribution |
| 6141-62-22 | Lumen/Inner Diameter 22.00 mm | In distribution |
| 6105-56-26 | Lumen/Inner Diameter 26 mm | In distribution |
| 6141-44-26 | Lumen/Inner Diameter 26.00 mm | In distribution |
| 6105-50-26 | Lumen/Inner Diameter 26.00 mm | In distribution |
| 6141-46-28 | 7 mm Offset | In distribution |
| 6110-76-28 | Lumen/Inner Diameter 28.00 mm | In distribution |
| 6105-74-26 | Lumen/Inner Diameter 26.00 mm | In distribution |
| 6105-36-22 | Lumen/Inner Diameter 22 mm | In distribution |
| 6110-60-22 | 10 Deg. Elevated Rim | In distribution |
| 6120-50-26 | Lumen/Inner Diameter 26.00 mm | In distribution |
| 6141-56-26 | 7 mm Offset | In distribution |
| 6120-40-22 | Lumen/Inner Diameter 22 mm | In distribution |
| 6141-66-32 | 7 mm Offset | In distribution |
| 6120-76-22 | Lumen/Inner Diameter 22.00 mm | In distribution |
| 6141-46-28 | 7 mm Offset | In distribution |
| 6105-78-22 | Lumen/Inner Diameter 22 mm | In distribution |
| 6110-76-28 | Lumen/Inner Diameter 28 mm | In distribution |
| 6110-60-22 | Lumen/Inner Diameter 22 mm | In distribution |
| 6105-76-28 | Lumen/Inner Diameter 28 mm | In distribution |
| 6105-70-32 | Lumen/Inner Diameter 32 mm | In distribution |
| 6105-66-28 | Lumen/Inner Diameter 28 mm | In distribution |
| 6141-46-26 | 7 mm Offset | In distribution |
| 6141-44-22 | Lumen/Inner Diameter 22.00 mm | In distribution |
| 6141-50-26 | 7 mm Offset | In distribution |
| 6141-42-26 | Lumen/Inner Diameter 26.00 mm | In distribution |
| 6141-58-28 | Lumen/Inner Diameter 28 mm | In distribution |
| 6105-60-28 | Lumen/Inner Diameter 28.00 mm | In distribution |
| 6105-80-22 | Lumen/Inner Diameter 22 mm | In distribution |
| 6105-48-32 | Lumen/Inner Diameter 32 mm | In distribution |
| 6105-68-28 | Lumen/Inner Diameter 28.00 mm | In distribution |
| 6120-40-22 | Lumen/Inner Diameter 22.00 mm | In distribution |
| 6105-68-32 | Lumen/Inner Diameter 32.00 mm | In distribution |
| 6141-48-22 | Lumen/Inner Diameter 22.00 mm | In distribution |
| 6120-68-22 | 20 Deg. Elevated Rim | In distribution |
| 6120-78-26 | Lumen/Inner Diameter 26 mm | In distribution |
| 6141-58-28 | Lumen/Inner Diameter 28.00 mm | In distribution |
| 6110-76-26 | 10 Deg. Elevated Rim | In distribution |
| 6105-48-32 | Lumen/Inner Diameter 32.00 mm | In distribution |
| 6141-64-32 | Lumen/Inner Diameter 32 mm | In distribution |
| 6141-66-22 | Lumen/Inner Diameter 22.00 mm | In distribution |
| 6105-66-22 | Lumen/Inner Diameter 22 mm | In distribution |
| 6105-62-28 | Lumen/Inner Diameter 28 mm | In distribution |
| 6110-48-32 | Lumen/Inner Diameter 32 mm | In distribution |
| 6105-58-28 | Lumen/Inner Diameter 28 mm | In distribution |
| 6120-50-22 | Lumen/Inner Diameter 22 mm | In distribution |
| 6105-68-26 | Lumen/Inner Diameter 26 mm | In distribution |
| 6120-44-26 | 20 Deg. Elevated Rim | In distribution |
| 6105-72-28 | Lumen/Inner Diameter 28 mm | In distribution |
| 6110-74-26 | 10 Deg. Elevated Rim | In distribution |
| 6110-56-28 | 10 Deg. Elevated Rim | In distribution |
| 6120-74-22 | 20 Deg. Elevated Rim | In distribution |
| 6110-60-28 | Lumen/Inner Diameter 28.00 mm | In distribution |
| 6110-58-22 | 10 Deg. Elevated Rim | In distribution |
| 6105-68-28 | Lumen/Inner Diameter 28 mm | In distribution |
| 6141-48-26 | Lumen/Inner Diameter 26 mm | In distribution |
| 6120-66-32 | 20 Deg. Elevated Rim | In distribution |
| 6141-44-26 | 7 mm Offset | In distribution |
| 6105-70-22 | Lumen/Inner Diameter 22 mm | In distribution |
| 6141-48-32 | 7 mm Offset | In distribution |
| 6120-42-22 | 20 Deg. Elevated Rim | In distribution |
| 6105-42-22 | Lumen/Inner Diameter 22 mm | In distribution |
| 6110-66-26 | 10 Deg. Elevated Rim | In distribution |
| 6141-48-22 | 7 mm Offset | In distribution |
| 6141-44-22 | 7 mm Offset | In distribution |
| 6105-56-22 | Lumen/Inner Diameter 22.00 mm | In distribution |
| 6120-66-22 | 20 Deg. Elevated Rim | In distribution |
| 6110-64-32 | 10 Deg. Elevated Rim | In distribution |
| 6110-44-28 | 10 Deg. Elevated Rim | In distribution |
| 6141-60-26 | Lumen/Inner Diameter 26.00 mm | In distribution |
| 6110-62-28 | Lumen/Inner Diameter 28.00 mm | In distribution |
| 6105-78-26 | Lumen/Inner Diameter 26 mm | In distribution |
| 6141-60-32 | Lumen/Inner Diameter 32 mm | In distribution |
| 6120-48-32 | 20 Deg. Elevated Rim | In distribution |
| 6120-60-32 | Lumen/Inner Diameter 32 mm | In distribution |
| 6120-76-26 | Lumen/Inner Diameter 26 mm | In distribution |
| 6120-64-22 | Lumen/Inner Diameter 22 mm | In distribution |
| 6120-48-26 | 20 Deg. Elevated Rim | In distribution |
| 6105-66-32 | Lumen/Inner Diameter 32 mm | In distribution |
| 6120-48-32 | Lumen/Inner Diameter 32.00 mm | In distribution |
| 6110-46-22 | Lumen/Inner Diameter 22.00 mm | In distribution |
| 6141-58-32 | 7 mm Offset | In distribution |
| 6105-58-26 | Lumen/Inner Diameter 26 mm | In distribution |
| 6110-46-22 | 10 Deg. Elevated Rim | In distribution |
| 6120-58-32 | Lumen/Inner Diameter 32 mm | In distribution |
| 6110-70-32 | Lumen/Inner Diameter 32.00 mm | In distribution |
| 6141-64-28 | Lumen/Inner Diameter 28 mm | In distribution |
| 6141-68-32 | 7 mm Offset | In distribution |
| 6105-74-22 | Lumen/Inner Diameter 22.00 mm | In distribution |
| 6141-58-26 | Lumen/Inner Diameter 26 mm | In distribution |
| 6141-50-28 | 7 mm Offset | In distribution |
| 6105-62-32 | Lumen/Inner Diameter 32.00 mm | In distribution |
| 6141-56-22 | 7 mm Offset | In distribution |
| 6141-58-22 | 7 mm Offset | In distribution |
| 6141-48-22 | 7 mm Offset | In distribution |
| 6120-44-26 | 20 Deg. Elevated Rim | In distribution |
| 6141-56-28 | 7 mm Offset | In distribution |
| 6105-56-28 | Lumen/Inner Diameter 28.00 mm | In distribution |
| 6141-64-32 | Lumen/Inner Diameter 32.00 mm | In distribution |
| 6105-66-26 | Lumen/Inner Diameter 26 mm | In distribution |
| 6105-66-32 | Lumen/Inner Diameter 32.00 mm | In distribution |
| 6105-68-22 | Lumen/Inner Diameter 22.00 mm | In distribution |
| 6110-74-28 | 10 Deg. Elevated Rim | In distribution |
| 6105-56-28 | Lumen/Inner Diameter 28 mm | In distribution |
| 6110-62-32 | 10 Deg. Elevated Rim | In distribution |
| 6141-68-22 | Lumen/Inner Diameter 22 mm | In distribution |
| 6110-80-28 | Lumen/Inner Diameter 28 mm | In distribution |
| 6141-68-32 | Lumen/Inner Diameter 32.00 mm | In distribution |
| 6141-70-28 | Lumen/Inner Diameter 28 mm | In distribution |
| 6110-66-28 | 10 Deg. Elevated Rim | In distribution |
| 6105-48-28 | Lumen/Inner Diameter 28 mm | In distribution |
| 6105-80-32 | Lumen/Inner Diameter 32.00 mm | In distribution |
| 6141-70-28 | 7 mm Offset | In distribution |
| 6141-64-28 | 7 mm Offset | In distribution |
| 6110-40-22 | Lumen/Inner Diameter 22.00 mm | In distribution |
| 6105-44-26 | Lumen/Inner Diameter 26.00 mm | In distribution |
| 6141-56-28 | Lumen/Inner Diameter 28 mm | In distribution |
| 6141-70-26 | Lumen/Inner Diameter 26.00 mm | In distribution |
| 6110-56-32 | 10 Deg. Elevated Rim | In distribution |
| 6120-56-32 | 20 Deg. Elevated Rim | In distribution |
| 6120-70-32 | 20 Deg. Elevated Rim | In distribution |
| 6120-78-28 | Lumen/Inner Diameter 28 mm | In distribution |
| 6110-74-28 | 10 Deg. Elevated Rim | In distribution |
| 6120-74-32 | 20 Deg. Elevated Rim | In distribution |
| 6141-68-26 | Lumen/Inner Diameter 26 mm | In distribution |
| 6105-62-26 | Lumen/Inner Diameter 26.00 mm | In distribution |
| 6110-72-26 | Lumen/Inner Diameter 26.00 mm | In distribution |
| 6105-72-28 | Lumen/Inner Diameter 28.00 mm | In distribution |
| 6141-64-22 | 7 mm Offset | In distribution |
| 6110-68-28 | Lumen/Inner Diameter 28.00 mm | In distribution |
| 6105-58-28 | Lumen/Inner Diameter 28.00 mm | In distribution |
| 6120-70-26 | 20 Deg. Elevated Rim | In distribution |
| 6105-58-26 | Lumen/Inner Diameter 26.00 mm | In distribution |
| 6105-72-26 | Lumen/Inner Diameter 26 mm | In distribution |
| 6120-72-22 | 20 Deg. Elevated Rim | In distribution |
| 6105-80-28 | Lumen/Inner Diameter 28 mm | In distribution |
| 6141-50-22 | Lumen/Inner Diameter 22 mm | In distribution |
| 6105-66-28 | Lumen/Inner Diameter 28.00 mm | In distribution |
| 6110-76-26 | Lumen/Inner Diameter 26.00 mm | In distribution |
| 6110-62-22 | Lumen/Inner Diameter 22 mm | In distribution |
| 6141-46-28 | Lumen/Inner Diameter 28 mm | In distribution |
| 6105-78-22 | Lumen/Inner Diameter 22.00 mm | In distribution |
| 6110-38-22 | 10 Deg. Elevated Rim | In distribution |
Showing 250 of 274 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sterrad™ | Advanced Sterilization Products Services Inc. | 18 |
| NexGen® | Zimmer, Inc. | 15 |
| Welch Allyn, Inc. | Welch Allyn, Inc. | 10 |
| V-PRO | Steris Mexico, S. de R.L. de C.V. | 7 |
| Amsco V-PRO | Steris Mexico, S. de R.L. de C.V. | 6 |
| SteroScope Insert Connector Large Assembly, Type 3, Qty 1 | Ideate Medical | 4 |
| Vaprox | Steris Corporation | 4 |
| Sterilink™ | Plasmapp Co., Ltd. | 3 |
| SteroScope Insert Connector Extra Small Assembly, Type R2, Qty 1 | Ideate Medical | 2 |
| Sterlink™ | Plasmapp Co., Ltd. | 2 |
| SteroScope Biopsy Connector Assembly, Type R1, Qty 1 | Ideate Medical | 2 |
| Sterrad NX™ | Advanced Sterilization Products Services Inc. | 2 |
Showing 12 of 34. All products under Sterilizer, Chemical
Recalls Naming This Product
15 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Zimmer Manufacturing B.V. | 510(k) number | 2016-05-04 | Class II | Packaging change control | A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws. | 3893 | 2017-07-05 |
| Zimmer Manufacturing B.V. | 510(k) number | 2016-01-11 | Class II | Packaging | As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. The affected products are sterile. | 87341 | 2017-04-13 |
| Zimmer Manufacturing B.V. | 510(k) number | 2016-01-11 | Class II | Packaging | As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. The affected products are sterile. | 2 | 2017-04-13 |
| Zimmer Manufacturing B.V. | 510(k) number | 2016-01-11 | Class II | Packaging | As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. The affected products are sterile. | 30 | 2017-04-13 |
| Zimmer Manufacturing B.V. | 510(k) number | 2016-01-11 | Class II | Packaging | As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. The affected products are sterile. | 400 | 2017-04-13 |
| Zimmer Manufacturing B.V. | 510(k) number | 2016-01-11 | Class II | Packaging | As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. The affected products are sterile. | 2063 | 2017-04-13 |
| Zimmer Manufacturing B.V. | 510(k) number | 2014-12-04 | Class II | Under Investigation by firm | Zimmer received a single complaint wherein a Trilogy® Fiber Metal Multi-Hole Acetabular Shell would not attach to the inserter/impactor instrumentation. Subsequent investigation found the polar-hole threads to be present but non-conforming | 68 units | 2015-06-18 |
| Zimmer Manufacturing B.V. | 510(k) number | 2014-11-21 | Class II | Equipment maintenance | Analysis of returned complaint devices, product in inventory, and device manufacturing records has identified tool marks isolated to one specific machining mill to be the cause of the fractures. . | 6,377 | 2015-08-10 |
| Zimmer, Inc. | 510(k) number | 2013-10-11 | Class II | Packaging | Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building | 7,044,680 total | 2017-04-14 |
| Zimmer, Inc. | 510(k) number | 2012-09-14 | Class II | Process control | Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the pore size specification (as low as 28% vs. 30% porosity specification). On 10/31/2012, the firm expanded the recall action to include lots of Uni | 275,952 units | 2014-06-20 |
| Zimmer, Inc. | 510(k) number | 2012-09-14 | Class II | Process control | Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the pore size specification (as low as 28% vs. 30% porosity specification). On 10/31/2012, the firm expanded the recall action to include lots of Uni | 275,952 units | 2014-06-20 |
| Zimmer, Inc. | 510(k) number | 2012-09-14 | Class II | Process control | Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the pore size specification (as low as 28% vs. 30% porosity specification). On 10/31/2012, the firm expanded the recall action to include lots of Uni | 275,952 units | 2014-06-20 |
| Zimmer, Inc. | 510(k) number | 2012-09-14 | Class II | Process control | Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the pore size specification (as low as 28% vs. 30% porosity specification). On 10/31/2012, the firm expanded the recall action to include lots of Uni | 275,952 units | 2014-06-20 |
| Zimmer, Inc. | 510(k) number | 2012-09-14 | Class II | Process control | Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the pore size specification (as low as 28% vs. 30% porosity specification). On 10/31/2012, the firm expanded the recall action to include lots of Uni | 275,952 units | 2014-06-20 |
| Zimmer, Inc. | 510(k) number | 2007-10-19 | Not classified | Process control | Parts missing and incomplete etch: The units may not contain the locking ring or the etched alignment marks on the rim. | 31 | 2008-05-21 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.