Identity™
48 catalogue numbers from SBHTRTM6, listed by Zimmer, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.
21manufacturers in China registered for this device type
48catalogue numbers in this listing
40recalls on this code
Who Else Makes It
Concentrated in Jiangsu (10), Shanghai (3), Zhejiang (2). 11 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Xinhua Healthcare Industry Co., Limited | Zibo | Shandong | Contract manufacturer | 30 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Sanbor Medical Xiamen, Inc. | Xiamen | Fujian | Contract manufacturer | 16 |
| Suzhou AND Science & Technology Development Corp. | Zhangjiagang | Jiangsu | Contract manufacturer | 5 |
| Guangzhou Clean Medical Products Manufacturing Corp | Guangzhou | Guangdong | Contract manufacturer | 5 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
Showing 12 of 21. All 21 manufacturers in China registered for Template
Record
| Listed by | Zimmer, Inc., United States |
|---|---|
| FDA product code | HWT |
| Device type | Template |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4800 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2022-09-22 |
| Record revised | 2022-10-18 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SBHTRTM6 | -6mm | In distribution |
| SBHTNE06 | +6mm | In distribution |
| SBHTST12 | +12mm | In distribution |
| SBHH5723 | 57mm X 23mm | In distribution |
| SBHTLTM6 | -6mm | In distribution |
| SBHH4817 | 48mm X 17mm | In distribution |
| SBHH4218 | 42mm X 18mm | In distribution |
| SBSP4000 | 40mm, 0mm/3mm | In distribution |
| SBHTST06 | +6mm | In distribution |
| SBHH3619 | 36mm X 19mm | In distribution |
| SBHLS400 | 40mm, +0mm Standard | In distribution |
| SBHH4522 | 45mm X 22mm | In distribution |
| SBHLR360 | 36mm, +0mm Retentive | In distribution |
| SBHLS403 | 40mm, +3mm Standard | In distribution |
| SBHLR400 | 40mm, +0mm Retentive | In distribution |
| SBHTNE12 | +12mm | In distribution |
| SBHLR363 | 36mm, +3mm Retentive | In distribution |
| SBHR3000 | In distribution | |
| SBSP3606 | 36mm, 6mm/9mm | In distribution |
| SBHH5121 | 51mm X 21mm | In distribution |
| SBHH5422 | 54mm X 22mm | In distribution |
| SBHH5726 | 57mm X 26mm | In distribution |
| SBHTNE00 | +0mm | In distribution |
| SBHH5118 | 51mm X 18mm | In distribution |
| SBHTLT00 | +0mm | In distribution |
| SBHH5124 | 51mm X 24mm | In distribution |
| SBHH3614 | 36mm X 14mm | In distribution |
| SBHH4823 | 48mm X 23mm | In distribution |
| SBSP4006 | 40mm, 6mm/9mm | In distribution |
| SBHH4820 | 48mm X 20mm | In distribution |
| SBHLR403 | 40mm, +3mm Retentive | In distribution |
| SBHLS363 | 36mm, +3mm Standard | In distribution |
| SBHH4519 | 45mm X 19mm | In distribution |
| SBSP3600 | 36mm, 0mm/3mm | In distribution |
| SBHHT001 | In distribution | |
| SBHTNEM6 | -6mm | In distribution |
| SBHH5720 | 57mm X 20mm | In distribution |
| SBHH3616 | 36mm X 16mm | In distribution |
| SBHH5425 | 54mm X 25mm | In distribution |
| SBHLS360 | 36mm, +0mm Standard | In distribution |
| SBHH4221 | 42mm X 21mm | In distribution |
| SBHTRT00 | +0mm | In distribution |
| SBHTST00 | +0mm | In distribution |
| SBHH4516 | 45mm X 16mm | In distribution |
| SBHH4215 | 42mm X 15mm | In distribution |
| SBHH5419 | 54mm X 19mm | In distribution |
| SBHH3920 | 39mm X 20mm | In distribution |
| SBHH3914 | 39mm X 14mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Attune | Depuy (Ireland) | 1,385 |
| Template | Exactech, Inc. | 1,277 |
| 4WEB Medical | 4WEB Inc. | 991 |
| Evolution® | Microport Orthopedics Inc. | 966 |
| Template | Zimmer, Inc. | 792 |
| Advance® | Microport Orthopedics Inc. | 644 |
| Apex Knee System | Omni Life Science, Inc. | 635 |
| Profemur® | Microport Orthopedics Inc. | 591 |
| Link Instruments – Trial implants and size gauges | Waldemar Link GmbH & Co. KG | 549 |
| Template | Synthes Gmbh | 516 |
| Optetrak Logic | Exactech, Inc. | 512 |
| Template | Depuy Spine, Inc. | 451 |
Showing 12 of 2,940. All products under Template
Recalls
27 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2013-11-19 | Class II | Labeling design | This is an expansion of the June 2013 recall of NexGen Micro components. Five (5) additional instruments have been identified that are associated only with the NexGen Micro components. There is the potential for these devices to be inadve | 439 units | 2015-05-06 |
| 2013-11-19 | Class II | Labeling design | This is an expansion of the June 2013 recall of NexGen Micro components. Five (5) additional instruments have been identified that are associated only with the NexGen Micro components. There is the potential for these devices to be inadve | 638 units | 2015-05-06 |
| 2013-11-19 | Class II | Labeling design | This is an expansion of the June 2013 recall of NexGen Micro components. Five (5) additional instruments have been identified that are associated only with the NexGen Micro components. There is the potential for these devices to be inadve | 684 units | 2015-05-06 |
| 2011-04-01 | Class II | Device Design | Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS) and the mating components (ie stems and provisional femoral necks), in some cases alleging the fit was too loose and in other cases, | 231,641 all lots, all sizes | 2014-05-16 |
| 2011-04-01 | Class II | Device Design | Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS) and the mating components (ie stems and provisional femoral necks), in some cases alleging the fit was too loose and in other cases, | 231,641 | 2014-05-16 |
| 2011-04-01 | Class II | Device Design | Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS) and the mating components (ie stems and provisional femoral necks), in some cases alleging the fit was too loose and in other cases, | 231,641 all lots, all sizes | 2014-05-16 |
| 2011-04-01 | Class II | Device Design | Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS) and the mating components (ie stems and provisional femoral necks), in some cases alleging the fit was too loose and in other cases, | 231,641 | 2014-05-16 |
| 2011-04-01 | Class II | Device Design | Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS) and the mating components (ie stems and provisional femoral necks), in some cases alleging the fit was too loose and in other cases, | 231, 641 all lots | 2014-05-16 |
| 2011-04-01 | Class II | Device Design | Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS) and the mating components (ie stems and provisional femoral necks), in some cases alleging the fit was too loose and in other cases, | 231,641 all lots, all sizes | 2014-05-16 |
| 2011-04-01 | Class II | Device Design | Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS) and the mating components (ie stems and provisional femoral necks), in some cases alleging the fit was too loose and in other cases, | 231,641 | 2014-05-16 |
| 2011-04-01 | Class II | Device Design | Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS) and the mating components (ie stems and provisional femoral necks), in some cases alleging the fit was too loose and in other cases, | 231,641 all lots, all sizes | 2014-05-16 |
| 2011-04-01 | Class II | Device Design | Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS) and the mating components (ie stems and provisional femoral necks), in some cases alleging the fit was too loose and in other cases, | 231641 all sizes | 2014-05-16 |
| 2011-04-01 | Class II | Device Design | Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS) and the mating components (ie stems and provisional femoral necks), in some cases alleging the fit was too loose and in other cases, | 231,641 | 2014-05-16 |
| 2011-04-01 | Class II | Device Design | Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS) and the mating components (ie stems and provisional femoral necks), in some cases alleging the fit was too loose and in other cases, | 231, 641 all lots | 2014-05-16 |
| 2011-04-01 | Class II | Device Design | Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS) and the mating components (ie stems and provisional femoral necks), in some cases alleging the fit was too loose and in other cases, | 231,641 all lots, all sizes | 2014-05-16 |
| 2010-11-15 | Not classified | Employee error | Mislabeled – Device packages labeled as hooded trial inserts contain standard trial inserts. | 3 | 2011-05-23 |
| 2010-10-10 | Class II | Device Design | Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been enhanced to inform users that the head may become difficult to visually locate if it becomes displaced deep or medial to the iliopsoas tendon and | 56,516 all lots, all sizes | 2014-04-30 |
| 2010-10-10 | Class II | Device Design | Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been enhanced to inform users that the head may become difficult to visually locate if it becomes displaced deep or medial to the iliopsoas tendon and | 128,946 all lots, all sizes | 2014-04-30 |
| 2010-10-10 | Class II | Device Design | Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been enhanced to inform users that the head may become difficult to visually locate if it becomes displaced deep or medial to the iliopsoas tendon and | 128,946 all lots, all sizes | 2014-04-30 |
| 2010-10-10 | Class II | Device Design | Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been enhanced to inform users that the head may become difficult to visually locate if it becomes displaced deep or medial to the iliopsoas tendon and | 56,516 all lots, all sizes | 2014-04-30 |
| 2010-10-10 | Class II | Device Design | Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been enhanced to inform users that the head may become difficult to visually locate if it becomes displaced deep or medial to the iliopsoas tendon and | 56,516 all lots, all sizes | 2014-04-30 |
| 2010-10-10 | Class II | Device Design | Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been enhanced to inform users that the head may become difficult to visually locate if it becomes displaced deep or medial to the iliopsoas tendon and | 128,946 all lots, all sizes | 2014-04-30 |
| 2010-10-10 | Class II | Device Design | Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been enhanced to inform users that the head may become difficult to visually locate if it becomes displaced deep or medial to the iliopsoas tendon and | 56,516 all lots, all sizes | 2014-04-30 |
| 2010-10-10 | Class II | Device Design | Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been enhanced to inform users that the head may become difficult to visually locate if it becomes displaced deep or medial to the iliopsoas tendon and | 56,516 all lots, all sizes | 2014-04-30 |
| 2010-10-10 | Class II | Device Design | Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been enhanced to inform users that the head may become difficult to visually locate if it becomes displaced deep or medial to the iliopsoas tendon and | 56,516 all lots, all sizes | 2014-04-30 |
| 2010-10-10 | Class II | Device Design | Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been enhanced to inform users that the head may become difficult to visually locate if it becomes displaced deep or medial to the iliopsoas tendon and | 128,946 all lots, all sizes | 2014-04-30 |
| 2010-10-10 | Class II | Device Design | Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been enhanced to inform users that the head may become difficult to visually locate if it becomes displaced deep or medial to the iliopsoas tendon and | 128,946 all lots, all sizes | 2014-04-30 |
| 2010-10-10 | Class II | Device Design | Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been enhanced to inform users that the head may become difficult to visually locate if it becomes displaced deep or medial to the iliopsoas tendon and | 128,946 all lots, all sizes | 2014-04-30 |
| 2008-12-12 | Not classified | Employee error | Some 12 mm thick devices may have been etched and packaged as 14 mm thick, and vice versa. | 131 of both products. | 2009-11-12 |
| 2008-12-12 | Not classified | Employee error | Some 12 mm thick devices may have been etched and packaged as 14 mm thick, and vice versa. | 131 of both products. | 2009-11-12 |
| 2006-10-19 | Not classified | Other | The instrument may fracture at the threaded end during intramedullary trialing and leave the distal pilot trial in the humeral canal. | 50 | 2007-12-05 |
| 2006-06-16 | Not classified | Other | During provisional trialing, the instrument may become stuck in the humeral canal and require surgical removal. | 324 total | 2007-12-05 |
| 2006-06-16 | Not classified | Other | During provisional trialing, the instrument may become stuck in the humeral canal and require surgical removal. | 324 total | 2007-12-05 |
| 2006-06-16 | Not classified | Other | During provisional trialing, the instrument may become stuck in the humeral canal and require surgical removal. | 324 total | 2007-12-05 |
| 2006-06-16 | Not classified | Other | During provisional trialing, the instrument may become stuck in the humeral canal and require surgical removal. | 324 total | 2007-12-05 |
| 2006-06-16 | Not classified | Other | During provisional trialing, the instrument may become stuck in the humeral canal and require surgical removal. | 324 total | 2007-12-05 |
| 2006-06-16 | Not classified | Other | During provisional trialing, the instrument may become stuck in the humeral canal and require surgical removal. | 324 total | 2007-12-05 |
| 2006-06-16 | Not classified | Other | During provisional trialing, the instrument may become stuck in the humeral canal and require surgical removal. | 324 total | 2007-12-05 |
| 2006-06-16 | Not classified | Other | During provisional trialing, the instrument may become stuck in the humeral canal and require surgical removal. | 324 total | 2007-12-05 |
| 2006-06-16 | Not classified | Other | During provisional trialing, the instrument may become stuck in the humeral canal and require surgical removal. | 324 total | 2007-12-05 |
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.