outer box: Ref 906768, CurvTek Eye Needle 22 MM X-large Stainless Steel, Single Use Gamma Sterilized, Rx inner incorrect
FDA device recall Z-0523-2014 · posted 2013-12-17 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- Reason for recall
- Inner label of PN: 906768 Lot: 055450 CurvTek Eye Needle 22mm X-Large states incorrectly PN: 906760 7mm Medium.
- Action taken
- Biomet sent an Urgent Medical Device Recall Notice dated November 26, 2013, to all affected customers. The notice identifies the product, problem, and actions to be taken by the customers. The letter included a Customer Response Form for customers to complete and return to the firm by FAX 574-372-1683. Customers with questions were instructed to call 574-372-1570. For questions regarding this recall call 574-372-1570.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- HTD
- Quantity affected
- 21
- Distribution
- Nationwide Distribution including MI, IA, IL, IN, and TN.
- Date initiated
- 2013-11-26
- Date posted
- 2013-12-17
- Date terminated
- 2015-07-07
- Location
- Warsaw, IN
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