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Terminated

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

FDA Recall Z-0993-2007 · Posted 2007-07-04

Recalling FirmBiomet, Inc.
Recall StatusTerminated
Product CodeFMF
Date Initiated2007-06-11
Date Terminated2007-12-05
Product Quantity46 to U.S. and international

Reason for Recall

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

Firm Action

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

Root Cause

Other

Distribution Pattern

Worldwide, including USA, Chile, Italy, Spain and United Kingdom.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K021071PCCS GRAFT DELIVERY SYSTEMBiomet, Inc. · 2002-07-01

Official Source

View FDA Recall →

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

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