Recall Z-0523-2014
Biomet, Inc. · initiated November 26, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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 follow the path of the tunnel created by the cartridges. This aligns the needle with the radius of the transosseous tunnel. Advance the needle while rotating the instrument away from the entry point. Gently feed the needle through the length of the tunnel.
Codes / lots: Lot 055450
Reason for recall
Inner label of PN: 906768 Lot: 055450 CurvTek Eye Needle 22mm X-Large states incorrectly PN: 906760 7mm Medium.
FDA-determined cause: Labeling mix-ups
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.
Details
- Recall number
- Z-0523-2014
- Initiated
- November 26, 2013
- Posted by FDA
- December 17, 2013
- Terminated
- July 7, 2015
- Product code
- HTD – Forceps
- Quantity
- 21
- Distribution
- Nationwide Distribution including MI, IA, IL, IN, and TN.
- Recalling firm
- Biomet, Inc., Warsaw, IN