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U.S. Department of Health and Human Services

Class 2 Device Recall Synthes 3.0 MM TI Cannulated Screw Instrument and Implant Set

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  Class 2 Device Recall Synthes 3.0 MM TI Cannulated Screw Instrument and Implant Set see related information
Date Initiated by Firm June 30, 2014
Date Posted August 19, 2014
Recall Status1 Terminated 3 on December 18, 2015
Recall Number Z-2265-2014
Recall Event ID 68738
510(K)Number K951304  K951304  
Product Classification Screw, fixation, bone - Product Code HWC
Product Synthes 3.0 MM TI Cannulated Screw Instrument and Implant Set
Code Information Part Number: 145.17E Lot Number: EV01609, individual part numbers contained within 145.17E:  304.49 309.501 310.221 310.804 311.43 312.151 312.153 313.969 314.463 314.464 314.465 319.291 319.292 319.702 319.97 398.408 398.409 402.608-402.640 402.714-402.740 419.89 419.972 292.622, and  292.623. 
Recalling Firm/
Manufacturer		 Synthes, Inc.
1302 Wrights Ln E
West Chester PA 19380-3417
For Additional Information Contact Customer Support
610-719-5000
Manufacturer Reason
for Recall		 A screw set was returned from the field for destruction after being exposed to flood water, which was erroneously reprocessed and returned to the field. Initial investigative testing indicated the components within the set may be cytotoxic.
FDA Determined
Cause 2		 Employee error
Action An Urgent Field Safety Notification, dated July 21, 2014, was sent to surgeons explaining the product, problem, and action to be taken with regard to routine post-operative follow-up on patients exposed to the affected product. Questions or concerns should be directed to Leonie Rynn at 610-719-5408 or lrynn1@its.jnj.com.
Quantity in Commerce 4
Distribution Distributed in the states of WI and MI.
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 = HWC and Original Applicant = SYNTHES (USA)
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