Biomet, Inc. Biomet Hybrid Glenoid Boss Cutter; item 406150. - Surgical instrument used to prepare the natural shoulder glenoid surface for implanting a Hybrid Glenoid component. This instrument is intended to function by drilling a hole into the natural glenoid surface allowing the center boss of glenoid implant to sit within the hole, and the non-articulating surface of the glenoid implant to rest flush onto the natural glenoid surface. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Biomet Hybrid Glenoid Boss Cutter; item 406150. - Surgical instrument used to prepare the natural shoulder glenoid surface for implanting a Hybrid Glenoid component. This instrument is intended to function by drilling a hole into the natural glenoid surface allowing the center boss of glenoid implant to sit within the hole, and the non-articulating surface of the glenoid implant to rest flush onto the natural glenoid surface.
Brand
Biomet, Inc.
Lot Codes / Batch Numbers
Lots 44550, 110100, 171760, 211530, 211550, 767940, 820310, 820330, 827250, 853810, 866590, 919780, 919790, 919800, 968270, 980230 and 980250.
Products Sold
Lots 44550, 110100, 171760, 211530, 211550, 767940, 820310, 820330, 827250, 853810, 866590, 919780, 919790, 919800, 968270, 980230 and 980250.
Biomet, Inc. is recalling Biomet Hybrid Glenoid Boss Cutter; item 406150. - Surgical instrument used to prepare the natural sh due to The glenoid implant may not seat fully on the face of the natural glenoid due to inadequate measurement tolerances (tolerance stack-up) in the design . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The glenoid implant may not seat fully on the face of the natural glenoid due to inadequate measurement tolerances (tolerance stack-up) in the design of the cutter. Use of the instrument may lead to incomplete seating of the glenoid implant, elevating the theoretical risk of glenoid loosening, which may lead to early revision surgery. The problem may contribute to early device failure and patien
Recommended Action
Per FDA guidance
Consignees were notified by Urgent Medical Device Removal Notice dated 3/13/08 to discontinue use of the instruments and return to the firm. Operating room managers were sent a separate letter dated 3/13/08 and informed of the possible effects to patients from previous use of this instrument and it was suggested they monitor patients for these effects. If you have any questions contact Mary Hardesty at 1-800-348-9500 or (574) 372-3983.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026