Biomet Hybrid Glenoid Boss Cutter recallZ-1658-2008 · Biomet, Inc. · initiated Mar 13, 2008
Terminated All recalls posted in September 2008
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Biomet, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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
FDA root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-1658-2008
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Mar 13, 2008
- Posted by the FDA
- Sep 16, 2008
- Recalling firm
- Biomet, Inc.
- Quantity
- 189
- Product code
- KWT
- FDA submissions
- K060694
- Distribution
- Class II Recall - Nationwide Distribution.
Product description
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.
Code information (models, lots, serial numbers)
Lots 44550, 110100, 171760, 211530, 211550, 767940, 820310, 820330, 827250, 853810, 866590, 919780, 919790, 919800, 968270, 980230 and 980250.
Other devices under the same FDA submission
5 devices cleared under K060694 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Comprehensive Modular Hybrid Glenoid SSI002231Biomet Orthopedics, LLC · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 recall0 reports
- Hybrid Glenoid PT-113950Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED22 reports
- COMPREHENSIVE SHOULDER SYSTEM 110004319Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- Comprehensive® Instruments 110003484Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED1 report
- Comprehensive® Shoulder System 110004319Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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