Zimmer Minimally Invasive Solutions Technology Offset Rasp Handle, Left, 45 degrees, non-sterile; Part number 00-7712-035-01.
FDA Recall Z-0671-06 · Posted 2006-03-21
Recalling FirmZimmer Inc.
Recall StatusTerminated
Product CodeLXH
Date Initiated2006-02-02
Date Terminated2007-12-05
Product Quantity495 left and right
Reason for Recall
A c-clip located near the rasp connection end of the instrument may detach during use and fall into the patient.
Firm 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.
Root Cause
Other
Distribution Pattern
Nationwide, Australia, Canada, Germany, Korea, Singapore and Taiwan.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.