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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 Posted August 09, 2013
Recall Status1 Terminated 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
610-719-5000
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 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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