FDA Medical Device Recalls (openFDA)
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 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.
- Recall number
- Z-0523-2014
- Recalling firm
- Biomet, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2013-11-26
- Posted
- 2013-12-17
- Terminated
- 2015-07-07
- 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.
- Lot, serial or model codes
- Lot 055450
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HTD
- Firm FEI
- 1825034
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28