Comprehensive reverse shoulder humeral tray with locking ring, 44 mm standard, sterile, single use, REF 115340, Biomet O
FDA device recall Z-2545-2011 · posted 2011-06-09 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- Reason for recall
- The firm is initiating this recall following an investigation which identified the rare possibility that certain units of Comprehensive Reverse Shoulder Humeral Trays may contain a locking ring that is incorrectly assembled.
- Action taken
- The firm, Biomet Orthopedics, sent an "URGENT MEDICAL DEVICE RECALL" letter dated April 22, 2011 to their customers. The letter describes the product, problem, and actions to be taken. The customers were instructed to immediately locate the recalled product; discontinue use; return the product back to Biomet; confirm receipt of the notice by calling 800-348-9500 extension 1368 or 1325, and complete and return the attached form via fax to: 574-372-1683 or mail to: Biomet, 56 East Bell Drive, Warsaw, IN 46580. Customers with questions regarding this recall should call 800-348-9500 extension 1368 or 1325.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- KWS
- Quantity affected
- 1575 all products
- Distribution
- Worldwide distribution: USA (nationwide) including: Puerto Rico and countries including: Australia, Canada, Chile, Columbia, Costa Rica, Korea and Netherlands.
- Date initiated
- 2011-04-22
- Date posted
- 2011-06-09
- Date terminated
- 2013-02-21
- Location
- Warsaw, IN
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| COMPREHENSIVE REVERSE SHOULDER (K080642) | Biomet, Inc. | 2008-07-09 |