Bio-Modular Humeral Head 48mm x 24mm Ti 6AI4V/Ion Implanted — Class II medical device recall Z-0474-2013
Terminated recall by Biomet, Inc., reported 2012-12-12, distributed nationwide. The items in this lot are missing the ion implantation feature. The surface of the head may be softer and more
| Recall number | Z-0474-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2012-11-01 |
| Classified | 2012-12-04 |
| Reported by FDA | 2012-12-12 |
| Terminated | 2013-08-29 |
| Distributed | Nationwide (US) |
| Quantity | 4 |
| Model numbers | 113740 |
Product
Bio-Modular Humeral Head 48mm x 24mm Ti 6AI4V/Ion Implanted (Orthopedic Implant) Product Usage: The OSS Knee Reamer Sleeves are primarily used to guide the bullet tip of cylindrical reamers during the tibial preparation in OSS procedures. They are reusable.
Reason for recall
The items in this lot are missing the ion implantation feature. The surface of the head may be softer and more prone to scratching, which in tum could potentially cause higher wear of the poly bearing. Increased wear could potentially lead to a shorter implant life.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0474-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.