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U.S. Department of Health and Human Services

Class 2 Device Recall USS Small Stature

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 Class 2 Recall
USS Small Stature
see related information
Date Posted August 09, 2013
Recall Status1 Open
Recall Number Z-1935-2013
Recall Event ID 65563
Premarket Notification
510(K) Number
K994121 
Product Classification Orthosis, Spinal Pedicle Fixation - Product Code MNI
Product 5.0mm Unit steel rod, pedicle screw spinal system. Intended to provide immobilization and stabilization of spinal segments in skeletally mature patients.
Code Information ALL LOTS of part numbers 298.269 and 298.278. Lot numbers were listed as: 4729951, 4841209, 4923651, 4923652, 4987688, 4987750, 5350635, 2002330, 3000595, 4729962, 4835378, 4856252, 4919165, 4923660, 4987686, 4987776, 5153851.
Recalling Firm/
Manufacturer
Synthes USA HQ, Inc.
1302 Wrights Ln E
West Chester, Pennsylvania 19380-3417
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Synthes Recall Information Center
610-719-5450
Manufacturer Reason
for Recall
DePuy Synthes has issued a Medical Device Correction notice for the 5.0mm Stainless Steel rods. This product was produced using a finishing process not identified as part of the manufacturing specification. No adverse event reports associated with the use of this product were received, and an extensive engineering and medical safety review concluded that the product poses no incremental risk to t
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action On June 5, 2013, De Puy Synthes notified by letter the direct acc acccounts which were identified to have received 5.0mm stainless steel rods and requested return of the product by calling 1-800-479-6329 to obtain a return authorization number. Completion of the verification section of the letter, including negative responses was also requested.
Quantity in Commerce 218
Distribution Nationwide Distribution.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MNI and Original Applicant = SYNTHES (USA)
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