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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmMarch 03, 2006
Date PostedMay 18, 2006
Recall Status1 Terminated 3 on December 04, 2007
Recall NumberZ-0872-06
Recall Event ID 34922
510(K)NumberK003496 
Product Classification Screw, Fixation, Bone - Product Code HWC
ProductZimmer 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.
Code Information Lots 51198300, 51217200, 51234800, 51260000 and 51302600.
Recalling Firm/
Manufacturer		 Pioneer Surgical Technology
375 River Park Cir
Marquette MI 49855-1781
For Additional Information Contact
800-846-4637
Manufacturer 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 Determined
Cause 2		Other
ActionPioneer 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 Commerce74
DistributionNationwide.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = HWC
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