Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0675-2007

Zimmer Trabecular Metal Reverse Shoulder System Instrumentation Conical Reamer, instrument for shoulder...

Zimmer GmbH / initiated 2007-02-01 / Terminated / root cause: design

Zimmer Inc. began a recall of Zimmer Trabecular Metal Reverse Shoulder System Instrumentation Conical Reamer, instrument for shoulder arthroplasty, REF no. 00-4309-021-00 on . The reason FDA records is "The reamer may lock up on the threads of the reamer body rather than spin freely as intended by design". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-0675-2007
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Zimmer GmbH
Product
Zimmer Trabecular Metal Reverse Shoulder System Instrumentation Conical Reamer, instrument for shoulder arthroplasty, REF no. 00-4309-021-00.
Product code
LXH Orthopedic Manual Surgical Instrument
Reason for recall
The reamer may lock up on the threads of the reamer body rather than spin freely as intended by design.
Root cause tag
design
FDA root cause
Other
Action
Zimmer sales staff was notified by letter dated 2/1/07 to pull any of the product from stock and to provide the name and address of their hospital customer accounts for further notification by Zimmer.
Quantity in commerce
4
Distribution
California, Ohio and Texas.
Product codes and lots
Lot 60605829.