510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
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
FDA enforcement reports joined to recall event Z-2483-2015
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2483-2015Class IITerminatedVoluntary: Firm initiated