Biomet Recalls OSS Knee Reamer Sleeves Due to Sticking Defect
Biomet is recalling 36 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 medical device with a functional defect that poses a risk of harm during a surgical procedure, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Biomet, Inc. is recalling 36 units of the OSS Reamer Sleeve (Part Numbers 32-472662, 13.0 thru 20.0). The affected lots are 154590, 156980, 519470, 519480, 542290, 628890, and 755530. These reusable stainless steel 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 defect where the thin shaft reamer may get stuck and not slide into the sleeve. The products were distributed worldwide, including nationwide in the United States, as well as in Japan and the Netherlands.
Healthcare facilities and users should stop using the affected devices and contact Biomet, Inc. for instructions on how to return or replace the products.
The recalled product
- Product
- OSS Reamer Sleeve REF132-472662 KNEE REAMER SLEEVE 13.0 thru 20.0 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.
- Hazard
- Affected units
- 36
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 (8)
- Part Numbers 32-472662
- 13.0 thru 20.0 Lot 154590
- 156980
- 519470
- 519480
- 542290
- 628890
- 755530
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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