Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0770-06

Zimmer M/L Taper Rasp Handle, Left, 45 degrees, non-sterile; Part number 83-7712-035-01. Recall Z-0671-06...

Zimmer GmbH / initiated 2006-02-02 / Terminated

Zimmer Inc. began a recall of Zimmer M/L Taper Rasp Handle, Left, 45 degrees, non-sterile; Part number 83-7712-035-01. Recall Z-0671-06 extended to include this product 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-0770-06
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Zimmer GmbH
Product
Zimmer M/L Taper Rasp Handle, Left, 45 degrees, non-sterile; Part number 83-7712-035-01. Recall Z-0671-06 extended to include this product.
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
32 right and Left
Distribution
Nationwide, Australia, Canada, Germany, Korea, Singapore and Taiwan.
Product codes and lots
Lots 08686700 and 08686500.