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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 Device Recall USS Small Stature see related information
Date Initiated by Firm June 05, 2013
Date Posted August 09, 2013
Recall Status1 Terminated 3 on September 21, 2015
Recall Number Z-1935-2013
Recall Event ID 65563
510(K)Number K020517  
Product Classification Orthosis, spinal pedicle fixation - Product Code MNI
Product 5.0mm Unit Rod 270mm
5.0mm Unit Rod 290mm
5.0mm Unit Rod 310mm
5.0mm Unit Rod 330mm
5.0mm Unit Rod 350mm
5.0mm Unit Rod 370mm
5.0mm Unit Rod 390mm
5.0mm Unit Rod 410mm
5.0mm Unit Rod 430mm
5.0mm Unit Rod 450mm

pedicle screw spinal system;
Intended to provide immobilization and stabilization of spinal segments in skeletally mature patients.
Code Information Part Numbers: 298.269 298.270 298.271 298.272 298.273 298.274 298.275 298.276 298.277 298.278  with lot numbers:  4729951; 4841209; 4923651; 4923652; 4987688; 4987750; 5350635; 2002330; 3000595 4729952; 4841210; 4923653; 4923654; 4987683; 4856248; 4987755; 5153848; 5153853; 1602596; 1880489 4729953; 4841211; 4923666; 4923667; 4987778; 4856275; 4987761; 5159826; 5157329; 3016224  4729954; 4841212; 4919162; 4923669; 4987779; 4856250; 4987766; 5153796; 3093619 4729956; 4923674; 4987825; 4987780; 5066363 4729958; 4923615; 4987826; 4987781; 5066364 4729959; 4841213; 4923655; 4936270; 4987684; 4987771; 5153849; 5153854 4729960; 4835367; 4923656; 4923657; 4984982; 4856246; 4987772; 5159827; 5157330  4729961; 4835368; 4923658; 4923659; 4987685; 4856249; 4987773; 1602617; 3080451 4729962; 4835378; 4919165; 4923660; 4987686; 4856252; 4987776; 5153851 
Recalling Firm/
Manufacturer		 Synthes USA HQ, Inc.
1302 Wrights Ln E
West Chester PA 19380-3417
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		 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 492
Distribution Nationwide Distribution.
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 = MNI and Original Applicant = SYNTHES (USA)
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