Endotec Prothesis Ankle, Titanium Alloy, Sterilized, BP… recallZ-1625-2010 · Endotec, Inc. · initiated Jun 5, 2009
Terminated All recalls posted in May 2010
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Endotec, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Endotec is recalling B-P Hip, B-P Shoulder, and B-P Knee Replacement System devices due to sterility issues involving validation, process variations and test results.
FDA root cause category: Other
What the company is doing
Recall Letters were sent to each distributor on 06/07/2009. Questions are directed to Endotec at (407) 822-0021.
Recall details
- Recall number
- Z-1625-2010
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jun 5, 2009
- Posted by the FDA
- May 20, 2010
- Recalling firm
- Endotec, Inc.
- Quantity
- 50 Pieces
- Product code
- JWH
- FDA submissions
- K842234, K904870, K960425
- Distribution
- Worldwide distribution -- US in OH, TX, CA, FL, NJ, TN; and International Distribution: Korea, Australia, Switzerland, The Netherlands, Spain. Domestic: OH, TX, CA, FL, NJ, TN.
Product description
Endotec Prothesis Ankle, Titanium Alloy, Sterilized, BP Ankle System. BP Ankle System, F-P Type III Ankle Bearing Component: 2x5mm F-P Type III Ankle Bearing Catalog: 05-13-0532, 2x7mm F-P Type III Ankle Bearing Catalog: 05-13-0732, 8x3mm F-P Type III Ankle Bearing Catalog: 05-13-0533, 8x1mm F-P Type III Ankle Bearing Catalog: 05-13-0731. BP Ankle System, F-P Type III Tibial Ankle Component: Size 1 F-P Type III Tibial Component Catalog: 05-12-0031, Size 2 F-P Type III Tibial Component Catalog: 05-12-0032, Size 3 F-P Type III Tibial Component Catalog: 05-12-0033. BP Ankle System, F-P Type III Talar Component: Size 1 F-P Type III Talar Component Catalog: 05-01-0031, Size 2 F-P Type III Talar Component Catalog: 05-01-0032, Size 3 F-P Type III Talar Component Catalog: 05-01-0033.
Code information (models, lots, serial numbers)
Lot No: 05010031BNN376 05010032BNN376 05010033BNN376 05010033CNN376 05120031BNN376 05120032BNN377 05120033BNN376 05130532BNN377 05130732BNN377 05130533BNN376 05130731BNN376
Other devices under the same FDA submission
7 devices cleared under K842234, K904870, K960425 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- SYNOVO HIP COMPONENTS 01-03-0049Synovo Production · Prosthesis, Hip, Femoral, Resurfacing1 recall0 reports
- SYNOVO HIP COMPONENTS 01-03-0051Synovo Production · Prosthesis, Hip, Femoral, Resurfacing1 recall0 reports
- SYNOVO HIP COMPONENTS 01-03-0044Synovo Production · Prosthesis, Hip, Femoral, Resurfacing1 recall0 reports
- SYNOVO HIP COMPONENTS 01-03-0047Synovo Production · Prosthesis, Hip, Femoral, Resurfacing1 recall0 reports
- SYNOVO HIP COMPONENTS 01-03-0045Synovo Production · Prosthesis, Hip, Femoral, Resurfacing1 recall0 reports
- SYNOVO HIP COMPONENTS 01-03-0042Synovo Production · Prosthesis, Hip, Femoral, Resurfacing1 recall0 reports
- SYNOVO HIP COMPONENTS 01-03-0052Synovo Production · Prosthesis, Hip, Femoral, Resurfacing1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 52527).
- Z-1624-2010 · TerminatedEndotec Prothesis Ankle, Titanium Alloy, Sterilized. BP Ankle System, Talar Ankle Component: Size 2 Talar Component Catalog: 05-01-0002, Size 3 Talar Component Catalog: 05-01-000…
- Z-1627-2010 · TerminatedEndotec Prothesis Ankle, Titanium Alloy, Sterilized, BP Ankle System. BP Ankle System, B-P Type II Talar Ankle Component: Size 1 B-P Type II Talar Ankle Component Catalog: 05-01-…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page