Recall Z-0523-2014 ยท HTD Forceps
Biomet, Inc.
outer box: Ref 906768, CurvTek Eye Needle 22 MM X-large Stainless Steel, Single Use Gamma Sterilized, Rx inner incorrect label: CurvTek 7 MM Medium, Single Pack Quantity -3, REF 906760 To pass the CurvTek needle, place the jaws of the instrument utilized to grasp the needle on the sides of the needle and orient and needle parallel to the long axis of the instrument. Position the needle to fol
| Date | Dec 17, 2013 (initiated Nov 26, 2013) |
| Status | Terminated |
| Reason | Inner label of PN: 906768 Lot: 055450 CurvTek Eye Needle 22mm X-Large states incorrectly PN: 906760 7mm Medium. |
| Root cause | Labeling mix-ups |
| Action | 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. |
| Quantity | 21 |
| Distribution | Nationwide Distribution including MI, IA, IL, IN, and TN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.