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.
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
