Z-0671-06
Zimmer Minimally Invasive Solutions Technology Offset Rasp Handle, Left, 45 degrees, non-sterile; Part number...
Zimmer GmbH / initiated 2006-02-02 / Terminated
Zimmer Inc. began a recall of Zimmer Minimally Invasive Solutions Technology Offset Rasp Handle, Left, 45 degrees, non-sterile; Part number 00-7712-035-01 on . The reason FDA records is "A c-clip located near the rasp connection end of the instrument may detach during use and fall into the patient". As of , the recall status on record is Terminated.
Recall record
- Recall number
- Z-0671-06
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Zimmer GmbH
- Product
- Zimmer Minimally Invasive Solutions Technology Offset Rasp Handle, Left, 45 degrees, non-sterile; Part number 00-7712-035-01.
- Product code
- LXH Orthopedic Manual Surgical Instrument
- Reason for recall
- A c-clip located near the rasp connection end of the instrument may detach during use and fall into the patient.
- FDA root cause
- Other
- Action
- Firm sales personnel were notified by letter dated 2/8/06 to visit each of their affected accounts and to remove the c-clip from the rasps or to remove the instrument from the hospital and return it to the firm. Similar instructions issued by letter dated 2/27/06 when the recall was extended to the two additional products.
- Quantity in commerce
- 495 left and right
- Distribution
- Nationwide, Australia, Canada, Germany, Korea, Singapore and Taiwan.
- Product codes and lots
- Lots 60244776, 60254445, 60270467, 60278638, 60298344, 60317739, 60330363 and 60342788.
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