Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0872-06

Zimmer Cannulated Screw System Cannulated Driver, 5.0 mm Hex, REF 1147-49-50; Catalog # 00-1147-049-50...

Pioneer Surgical Technology began a recall of Zimmer Cannulated Screw System Cannulated Driver, 5.0 mm Hex, REF ; Catalog # 00-1147-049-50. Manufactured by Pioneer Surgical Technology, Marquette... on . The reason FDA records is "There may be an obstruction in the cannula that will prevent the guide wire from passing through it. The obstruction in the cannula can force the guidewire to advance further into the patient than intended". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0872-06
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Product
Zimmer Cannulated Screw System Cannulated Driver, 5.0 mm Hex, REF 1147-49-50; Catalog # 00-1147-049-50. Manufactured by Pioneer Surgical Technology, Marquette, MI; Distributed by Zimmer, Warsaw, IN.
Product code
HWC Screw, Fixation, Bone
Reason for recall
There may be an obstruction in the cannula that will prevent the guide wire from passing through it. The obstruction in the cannula can force the guidewire to advance further into the patient than intended.
FDA root cause
Other
Action
Pioneer notified Zimmer via letter dated 3/3/06 and Zimmer notified their hospital customers and distribution sites via letters dated 3/10/06 to check their inventory and return the product immediately to Zimmer.
Quantity in commerce
74
Distribution
Nationwide.
Product codes and lots
Lots 51198300, 51217200, 51234800, 51260000 and 51302600.