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U.S. Department of Health and Human Services

Class 2 Device Recall Synthes 5.0mm Unit Stainless Steel Rods for the Synthes Small Stature USS

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  Class 2 Device Recall Synthes 5.0mm Unit Stainless Steel Rods for the Synthes Small Stature USS see related information
Date Initiated by Firm September 04, 2015
Date Posted October 17, 2015
Recall Status1 Terminated 3 on August 26, 2016
Recall Number Z-0134-2016
Recall Event ID 72134
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; Orthosis, Spinal, Pedicle fixation

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 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; and 5153851. 
Recalling Firm/
Manufacturer		 Synthes (USA) Products LLC
1301 Goshen Pkwy
West Chester PA 19380-5986
For Additional Information Contact Customer Support
610-719-6500
Manufacturer Reason
for Recall		 This product was produced using a finishing process not identified as part of the manufacturing specification. The process used with the lots subject to this Recall was a bead blast process. (Bead Blasting vs. Shot Peened).
FDA Determined
Cause 2		 Process control
Action An Urgent Notice: Medical Device Recall, dated September 4, 2015, was sent to end users to alert them about the issue and possible risk to patients. Customers were requested to follow the actions to be taken for if they have affected product or not; complete the response form, and return affected product. Customers can call 610-719-5450 or a local Synthes Sales Consultant with any questions.
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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