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Terminated

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.

FDA Recall Z-0523-2014 · Posted 2013-12-17

Recalling FirmBiomet, Inc.
Recall StatusTerminated
Product CodeHTD
Date Initiated2013-11-26
Date Terminated2015-07-07
Product Quantity21

Reason for Recall

Inner label of PN: 906768 Lot: 055450 CurvTek Eye Needle 22mm X-Large states incorrectly PN: 906760 7mm Medium.

Firm 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.

Root Cause

Labeling mix-ups

Distribution Pattern

Nationwide Distribution including MI, IA, IL, IN, and TN.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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