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Terminated

TI ANCHOR 1.9MM W / 2-0 SUTURE, G-FORCE SUTURE ANCHOR, Tissue Anchor, REF 86TA-1920, Rx ONLY, Sterile EO, Wright, Arlington, TN USA Used in the repair of tendons and ligaments

FDA Recall Z-1524-2011 · Posted 2011-03-04

Recalling FirmWright Medical Technology Inc
Recall StatusTerminated
Product CodeMBI
Date Initiated2011-01-11
Date Terminated2011-07-11
Product Quantity10 units

Reason for Recall

Driver may break during use.

Firm Action

Wright Medical Technology Inc initiated their recall of the product by telephone to their distributors on January 11, 2011. The firm followed with letters sent on February 1, 2011, to distributors, hospital administrators, and surgeons. Distributors were asked to immediately complete the attached response form, confirming receipt of the notice, and return a copy to Wright Medical by fax to 901-867-4788. For questions they were instructed to call 800-874-5630. For questions regarding this recall call 901-867-4788.

Root Cause

Other

Distribution Pattern

Nationwide Distribution including FL, NC, OH, IL, IN

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K100579G-FORCE TI SUTURE ANCHOR SYSTEMWrightmedicaltechnologyinc · 2010-03-26

Official Source

View FDA Recall →

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

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