Recalls / —
—#139224
Product
Vision RingLoc Shell 50 mm Size 23. Hip joint replacement prosthesis.
- FDA product code
- LPH — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- Device class
- Class 2
- Medical specialty
- Orthopedic
- 510(k) numbers
- K093235
- Affected lot / code info
- Part Number:135250; Lot Number:946410
Why it was recalled
The device was assembled without screw hole plugs.
Root cause (FDA determination)
Under Investigation by firm
Action the firm took
Zimmer Biomet issued notices on July 28, 2015, via FedEx overnight mail and e-mail to customers. Customers were asked to return response forms and recalled devices to Zimmer Biomet. Customers with questions may call Seth Pixton, Field Action Specialist, at 574-372-1570, Monday through Friday from 8:00 am to 5:00 pm, or e-mail at: seth.pixton@zimmerbiomet.com.
Recalling firm
- Firm
- Biomet, Inc.
- Address
- 56 E Bell Dr, Warsaw, Indiana 46582-6989
Distribution
- Distribution pattern
- Distributed in Canada and Japan.
Timeline
- Recall initiated
- 2015-07-28
- Posted by FDA
- 2015-08-29
- Terminated
- 2016-05-17
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #139224. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.