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Terminated

FAST-FIX AB Curved Needle Delivery System, Used for meniscal repair. Product Number: 7209399

FDA Recall Z-0798-06 · Posted 2006-04-26

Recalling FirmSmith & Nephew, Inc. Endoscopy Division
Recall StatusTerminated
Product CodeKGS
Date Initiated2006-03-24
Date Terminated2007-12-12
Product Quantity1800 units

Reason for Recall

The implant consists of a T1 and T2 anchor which are joined together by a suture. The T2 portion of the implant may not advance into the deployment position preventing deployment of the T2 anchor.

Firm Action

Smith & Nephew notified accounts by letter dated 3/24/06 issued by Federal Express. Users are requested to return product.

Root Cause

Other

Distribution Pattern

Nationwide Foreign: Austria, Germany, France, Italy, Australia

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K020480RBMSmith & Nephew, Inc. · 2002-03-12

Official Source

View FDA Recall →

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

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