Biomet Recalls OSS Knee Reamer Sleeves Due to Sticking Risk
Biomet is recalling 46 OSS Knee Reamer Sleeves because the thin shaft reamer may get stuck and fail to slide into the sleeve.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product where the device may malfunction (get stuck) during a surgical procedure, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Biomet, Inc. is recalling 46 units of the OSS Reamer Sleeve (Part Numbers 32-472661, sizes 8.0 through 12.5). These reusable stainless steel medical devices are used to guide the bullet tip of cylindrical reamers during tibial preparation in OSS procedures.
The recall was initiated following an investigation that identified a risk that the thin shaft reamer may get stuck and not slide into the sleeve. The affected units were distributed worldwide, including the United States (nationwide), Japan, and the Netherlands.
Healthcare facilities and users should stop using the affected OSS Knee Reamer Sleeves and contact Biomet for instructions on how to return the devices.
The recalled product
- 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.
- Manufacturer
- Biomet, Inc.
- Affected units
- 46
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- Part Numbers 32-472661
- 8.0 thru 12.5 Lot 013020
- 050310
- 056280
- 154670
- 418380
- 691220
- 755510
- 860171
- 866460
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Biomet, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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