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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm March 03, 2006
Date Posted May 18, 2006
Recall Status1 Terminated 3 on December 04, 2007
Recall Number Z-0872-06
Recall Event ID 34922
510(K)Number K003496  
Product Classification Screw, Fixation, Bone - Product Code HWC
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.
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
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.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = HWC and Original Applicant = PIONEER SURGICAL TECHNOLOGY
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