Recalls / —

—#82569

Product

Zimmer Pulsavac Wound Debridement System high capacity intramedullary brush tip, sterile, Zimmer, Dover, Ohio; Catatog Number: 00515018300. Used in conjunction with the Pulsavac Plus Wound Debridement System for pulsatile lavage/debridement.

FDA product code

FQH — Lavage, Jet

Device class

Class 2

Medical specialty

General Hospital

Affected lot / code info

Lot Number: 61229259.

Why it was recalled

The seal on the sterile barrier pouch may be inadequate, resulting in lack of assurance of sterility.

Root cause (FDA determination)

Packaging process control

Action the firm took

Zimmer Orthopedic Surgical Products issued an "Urgent: Medical Device Recall" notice dated June 8, 2009 informing users of the affected devices and actions to be taken including the return of product and acknowledgement of receipt of notice by returning the Recall Certification Form by fax to 1-330-364-0974.

Recalling firm

Firm

Zimmer Inc.

Address

345 E Main St, Warsaw, Indiana 46580-2746

Distribution

Distribution pattern

Worldwide Distribution -- United States, Canada and Japan.

Timeline

Recall initiated

2009-06-08

Posted by FDA

2009-07-23

Terminated

2009-12-15

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #82569. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.