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.
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