FDA Device recall Z-0471-2013
OSS Reamer Sleeve REF132-472661 KNEE REAMER SLEEVE 8.0 THRU 12.5 STAINLESS STEEL The OSS Knee Reamer Sleeves are primarily used to guide th…
- FDA Device
- Class II
- terminated
- Published 2012-12-12
On 2012-12-12 the FDA classified a Class II recall of OSS Reamer Sleeve REF132-472661 KNEE REAMER SLEEVE 8.0 THRU 12.5 STAINLESS STEEL The OSS Knee Reamer Sleeves are primarily used to guide th… by Biomet, citing biomet has initiated this action following an investigation which identified that the thin shaft reamer may get stuck and not slide into the sleeve.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0471-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-11-01 |
| Published | 2012-12-12 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Biomet |
| Distribution | US |
Product
OSS Reamer Sleeve REF132-472661 KNEE REAMER SLEEVE 8.0 THRU 12.5 STAINLESS STEEL 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
Biomet has initiated this action following an investigation which identified that the thin shaft reamer may get stuck and not slide into the sleeve.
Identifiers
| code_info | Part Numbers 32-472661 , 8.0 thru 12.5 Lot 013020, 050310, 056280, 154670, 418380, 691220, 755510, 860171, 866460 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0471-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.