Recalls / —
—#52983
Product
Vortech Graft Preparation System, sterile, single use, disposable, Distributed by Biomet Biologics, Inc., Warsaw, Indiana; REF 800-0300V. (Not sold in the United States).
- FDA product code
- FMF — Syringe, Piston
- Device class
- Class 2
- Medical specialty
- General Hospital
- Affected lot / code info
- Lot 192380, exp. Jan 2012.
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 #52983. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.