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U.S. Department of Health and Human Services

Class 2 Device Recall Quantum Spinal

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  Class 2 Device Recall Quantum Spinal see related information
Date Initiated by Firm July 29, 2005
Date Posted August 31, 2005
Recall Status1 Terminated 3 on October 25, 2005
Recall Number Z-1457-05
Recall Event ID 32918
510(K)Number K041156  
Product Classification Device, Detection, Sulfide - Product Code MVH
Product Pioneer Surgical brand Quantum Spinal Rod System Locking Cap; Catalog No 10-LCAP.
Code Information Lots 306456, 306457, 306613, 306712, 306713, 306714, 306816, 306817, 306818, 306819, 306820, 306821, 306822, 307526, 307527, 307528, 307667, 307668, 308510, 308938, 310662, 310663, 310664, 310665, 311718, 312169, 519935 and 521042.
Recalling Firm/
Manufacturer		 Pioneer Surgical Technology
375 River Park Cir
Marquette MI 49855-1781
For Additional Information Contact Dan Nelson
906-226-4489
Manufacturer Reason
for Recall		 The product has a higher than normal locking torque, which may cause the saddle to malfunction or to break interoperatively.
FDA Determined
Cause 2		 Other
Action Distributors were notified via letter dated July 29, 2005 to retrieve all caps from inventory and point of use locations and to return them to Pioneer.
Quantity in Commerce 5069
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 = MVH and Original Applicant = NONIN MEDICAL, INC.
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