Prosthesis, Elbow, Constrained, Cemented
37 catalogue numbers from 32-8106-00-13, listed by Zimmer, Inc., United States, under Prosthesis, Elbow, Constrained, Cemented. 1 manufacturer in China is registered for this product code.
1manufacturer
37catalogue numbers in this listing
8510(k) clearances naming this product code
14recalls on this code
Who Else Makes It
Registered in Shanghai.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
Record
| Listed by | Zimmer, Inc., United States |
|---|---|
| FDA product code | JDC |
| Device type | Prosthesis, Elbow, Constrained, Cemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3150 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K181307 |
| Record published | 2015-09-17 |
| Record revised | 2021-10-18 (version 5) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Sizes | Length 3 to 8 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 32-8106-00-13 | In distribution | |
| 32-8105-26-04 | Length 4 in | In distribution |
| 32-8105-73-02 | Length 4.5 in | In distribution |
| 32-8105-53-02 | Length 3 in | In distribution |
| 32-8105-29 | In distribution | |
| 32-8105-27-01 | In distribution | |
| 32-8105-26-08 | Length 8 in | In distribution |
| 32-8105-25-06 | Length 6 in | In distribution |
| 32-8105-63-02 | Length 3.5 in | In distribution |
| 32-8105-93-01 | Length 4.5 in | In distribution |
| 32-8105-043-01 | Length 3 in | In distribution |
| 32-8105-25-01 | In distribution | |
| 32-8106-00-12 | In distribution | |
| 32-8105-25-04 | Length 4 in | In distribution |
| 32-8105-25-01 | In distribution | |
| 32-8105-25-08 | Length 8 in | In distribution |
| 32-8105-53-01 | Length 3 in | In distribution |
| 32-8106-00-13 | In distribution | |
| 32-8105-36-06 | Length 6 in | In distribution |
| 32-8105-36-08 | Length 8 in | In distribution |
| 32-8105-043-02 | Length 3 in | In distribution |
| 32-8105-27-04 | Length 4 in | In distribution |
| 32-8105-35-08 | Length 8 in | In distribution |
| 32-8105-27-01 | In distribution | |
| 32-8105-26-06 | Length 6 in | In distribution |
| 32-8105-63-01 | Length 3.5 in | In distribution |
| 32-8105-30 | In distribution | |
| 32-8105-29 | In distribution | |
| 32-8105-83-02 | Length 4.5 in | In distribution |
| 32-8105-93-02 | Length 4.5 in | In distribution |
| 32-8105-30 | In distribution | |
| 32-8105-25-04 | Length 4.00 in | In distribution |
| 32-8105-27-06 | Length 6 in | In distribution |
| 32-8105-83-01 | Length 4.5 in | In distribution |
| 32-8105-73-01 | Length 4.5 in | In distribution |
| 32-8106-00-12 | In distribution | |
| 32-8105-35-06 | Length 6 in | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Nexel® | Zimmer, Inc. | 78 |
| DJO Surgical | Encore Medical, L.P. | 74 |
| Tema Elbow | Limacorporate | 72 |
| Discovery Elbow System | Biomet Orthopedics | 72 |
| Arcos Modular Revision Hip System | Biomet Orthopedics | 58 |
| Latitude™ – Elbow | Tornier Inc. | 38 |
| Latitude™ EV | Tornier Inc. | 36 |
| Comprehensive® SRS | Biomet Orthopedics | 31 |
| Comprehensive® SRS Instrument | Biomet Orthopedics | 30 |
| Solar | Howmedica Osteonics Corp | 27 |
| Zimmer® Nexel® Total Elbow | Zimmer, Inc. | 23 |
| Arrow | Teleflex Medical LLC | 13 |
Showing 12 of 28. All products under Prosthesis, Elbow, Constrained, Cemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K181307 | 2019-01-28 |
| K150501 | 2015-04-23 |
| K123862 | 2013-03-12 |
| K053189 | 2005-12-09 |
| K040389 | 2004-05-17 |
| K001989 | 2000-07-25 |
| K973357 | 1998-03-02 |
| K883665 | 1989-02-03 |
Recalls Naming This Product
13 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, Inc. | 510(k) number | 2019-12-12 | Class II | Under Investigation by firm | The lot contained two outer pins instead of one outer and one inner pin. | 3 | 2021-01-13 |
| Zimmer, Inc. | 510(k) number | 2019-10-10 | Class II | Packaging change control | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 5,459,583 total devices | 2020-05-19 |
| Zimmer, Inc. | 510(k) number | 2018-01-24 | Class II | Under Investigation by firm | One lot of humeral stem implants do not include the humeral bushing components. | 9 | 2019-04-09 |
| Zimmer, Inc. | 510(k) number | 2016-08-16 | Class II | Process design | Zimmer Biomet is conducting a voluntary medical device recall of a single lot of the Coonrad/ Morrey Elbow Pin/ Bushing Replacement size Kit Extra Small because the lot was packaged with a missing humeral bushing. The missing bushing could | 25 units | 2017-06-12 |
| Zimmer, Inc. | 510(k) number | 2012-11-19 | Class II | Process change control | Zimmer is initiating a lot specific recall because affected lots could include an extra Small Inner Pin instead of the required Regular Inner Pin in the Coonrad/Morrey Elbow Replacement Set and the New Ulnar Revision Kit. | 23 | 2014-04-17 |
| Zimmer, Inc. | 510(k) number | 2012-11-19 | Class II | Process change control | Zimmer is initiating a lot specific recall because affected lots could include an extra Small Inner Pin instead of the required Regular Inner Pin in the Coonrad/Morrey Elbow Replacement Set and the New Ulnar Revision Kit. | 17 | 2014-04-17 |
| Zimmer, Inc. | 510(k) number | 2009-01-30 | Not classified | Labeling design | The surgical technique is inadequate for extra-small sized implants, resulting in the possibility of the provisional becoming stuck in the bone. | 14,613 of all products | 2009-12-22 |
| Zimmer, Inc. | 510(k) number | 2009-01-30 | Not classified | Labeling design | The surgical technique is inadequate for extra-small sized implants, resulting in the possibility of the provisional becoming stuck in the bone. | 14,613 of all products | 2009-12-22 |
| Zimmer, Inc. | 510(k) number | 2009-01-30 | Not classified | Labeling design | The surgical technique is inadequate for extra-small sized implants, resulting in the possibility of the provisional becoming stuck in the bone. | 14,613 of all products | 2009-12-22 |
| Zimmer, Inc. | 510(k) number | 2009-01-30 | Not classified | Labeling design | The surgical technique is inadequate for extra-small sized implants, resulting in the possibility of the provisional becoming stuck in the bone. | 14,613 of all products | 2009-12-22 |
| Zimmer, Inc. | 510(k) number | 2009-01-30 | Not classified | Labeling design | The surgical technique is inadequate for extra-small sized implants, resulting in the possibility of the provisional becoming stuck in the bone. | 14,613 of all products | 2009-12-22 |
| Zimmer, Inc. | 510(k) number | 2009-01-30 | Not classified | Labeling design | The surgical technique is inadequate for extra-small sized implants, resulting in the possibility of the provisional becoming stuck in the bone. | 14,613 of all products | 2009-12-22 |
| Zimmer, Inc. | 510(k) number | 2004-03-16 | Not classified | Other | Right ulna implants were etched and labeled as left ulna implants. Left ulna implants may have been etched and labeled as right ulna implants. | 2004-06-26 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Closed |
|---|---|---|---|---|
| 2004-03-16 | Not classified | Other | right ulna implants were etched and labeled as left ulna implants. Left ulna implants may have been etched and labeled as right ulna implants. | 2004-06-26 |
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.