Biomet Hybrid Glenoid Boss Cutter; item 406150. - Surgical instrument used to prepare the natural shoulder glenoid surfa
FDA device recall Z-1658-2008 · posted 2008-09-16 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- Reason for recall
- 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
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- KWT
- Quantity affected
- 189
- Distribution
- Class II Recall - Nationwide Distribution.
- Date initiated
- 2008-03-13
- Date posted
- 2008-09-16
- Date terminated
- 2008-10-15
- Location
- Warsaw, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODULAR HYBRID GLENOID (K060694) | Biomet Manufacturing Corp | 2006-12-11 |