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.

Recall Insight

This FDA Devices action (record #Z-0472-2013) was formally reported on December 12, 2012, with the manufacturer initiating the action on November 1, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. Biomet, Inc. is listed as the recalling firm, operating out of Warsaw, IN. Federal records indicate 36 units are affected.

The documented reason for this recall is: Biomet has initiated this action following an investigation which identified that the thin shaft reamer may get stuck and not slide into the sleeve. Distribution data in the federal record shows the product reached: Worldwide distribution: USA (nationwide) and countries of: Japan and Netherlands.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 14 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.