—#52981

Product

Graft Preparation System, sterile, single use, disposable, Distributed by Biomet Biologics, Inc., Warsaw, Indiana; REF 800-0300.

FDA product code: FMF — Syringe, Piston
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K021071
Affected lot / code info: Lots 192180, exp. Jan 2012; 223260, exp. Jan 2012 and 652330, exp May 2011.

Why it was recalled

The syringe assembly has an obstruction in the tube that prevents the plunger from being depressed.

Root cause (FDA determination)

Other

Action the firm took

Consignees were notified by letter dated either 6/11/07 or 6/13/07 and requested to return the product.

Recalling firm

Firm: Biomet, Inc.
Address: 56 E Bell Dr, Warsaw, Indiana 46581-0587

Distribution

Distribution pattern: Worldwide, including USA, Chile, Italy, Spain and United Kingdom.

Timeline

Recall initiated: 2007-06-11
Posted by FDA: 2007-07-04
Terminated: 2007-12-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #52981. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.