ClearanceBrief
Recall Z-0675-2007 ยท LXH Orthopedic Manual Surgical Instrument

Zimmer Inc.

Zimmer Trabecular Metal Reverse Shoulder System Instrumentation Conical Reamer, instrument for shoulder arthroplasty, REF no. 00-4309-021-00.

DateMar 29, 2007 (initiated Feb 1, 2007)
StatusTerminated
ReasonThe reamer may lock up on the threads of the reamer body rather than spin freely as intended by design.
Root causeOther
ActionZimmer 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.
Quantity4
DistributionCalifornia, Ohio and Texas.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.