REF. CP113456, MAK OSS No Head Lock Pin, NO HEAD / WITH… recallZ-1438-2012 · Biomet, Inc. · initiated Mar 20, 2012
Terminated All recalls posted in April 2012
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 Biomet, 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
Biomet initiated this action after receiving complaints of the MAK OSS No Head Lock Pin dislodging from its intended position (post-initial surgery). An investigation was initiated and the available lots of the Lock Pin were evaluated and measured against print specifications.
FDA root cause category: Component design/selection
What the company is doing
Biomet sent an "URGENT MEDICAL DEVICE SAFETY ALERT" letter dated March 20, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to continue monitoring implanted patients for disassociation of the pin component and report to Biomet. The Alert included a complete listing of device invoice history and patient information (if supplied). Contact the firm for confirmation of receipt of the notice and for questions at 574-372-3983.
Recall details
- Recall number
- Z-1438-2012
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Mar 20, 2012
- Posted by the FDA
- Apr 19, 2012
- Recalling firm
- Biomet, Inc.
- Quantity
- 64 units distributed
- Product code
- KRO
- FDA submissions
- K083779
- Distribution
- Distributed in California and Pennsylvania.
Product description
REF. CP113456, MAK OSS No Head Lock Pin, NO HEAD / WITH PLUG CO-CR-MO ALLOY/ARCOM UHMWPE STERILE, R, Biomet Orthopedics Warsaw, IN 46581. The MAK OSS No Head Metal Lock Pin is to be inserted into the anterior hole of the tibial bearing yoke to secure the OSS Axle in the correct position within the OSS Femoral component assembly.
Code information (models, lots, serial numbers)
Catalog number: CP113456 with lot numbers: 593310, 743610, 750120, 815030, and 815040.
Other devices under the same FDA submission
1 device cleared under K083779 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- OSS™ Orthopedic Salvage System CP113836Biomet Orthopedics, LLC · PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER1 report
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.
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