Z-2483-2015Class II
Vision RingLoc Shell 50 mm Size 23. Hip joint replacement prosthesis
Zimmer GmbH / initiated 2015-07-28 / Terminated
Biomet, Inc. began a recall of Vision RingLoc Shell 50 mm Size 23. Hip joint replacement prosthesis on . FDA classified it as Class II and gives the reason as "The device was assembled without screw hole plugs". As of , the recall status on record is Terminated.
Recall record
- Recall number
- Z-2483-2015
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Zimmer GmbH
- Product
- Vision RingLoc Shell 50 mm Size 23. Hip joint replacement prosthesis.
- Product code
- LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- Reason for recall
- The device was assembled without screw hole plugs.
- FDA root cause
- Under Investigation by firm
- Action
- 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: [email protected].
- Quantity in commerce
- 5
- Distribution
- Distributed in Canada and Japan.
- Product codes and lots
- Part Number:135250; Lot Number:946410
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2483-2015 | Class II | Terminated | Voluntary: Firm initiated |
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