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U.S. Department of Health and Human Services

Class 2 Device Recall Synthes Sciatic Nerve Retractor and Sciatic Nerve Retractor Long

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  Class 2 Device Recall Synthes Sciatic Nerve Retractor and Sciatic Nerve Retractor Long see related information
Date Initiated by Firm July 29, 2015
Date Posted August 19, 2015
Recall Status1 Terminated 3 on May 19, 2016
Recall Number Z-2418-2015
Recall Event ID 71869
Product Classification Retractor - Product Code GAD
Product Synthes Sciatic Nerve Retractor and Sciatic Nerve Retractor Long; Synthes Sciatic Nerve Retractor and Sciatic Nerve Retractor Long are system specific instruments to the 3.5 mm Low Profile Pelvic System Retractor Set.
Code Information Part Numbers 03.100.013 03.100.014 with lot numbers: 5001180 5001181 5043720 5043721 5043722 5043723 5056224 5056410 5056411 5101097 5106064 5109323 5162016 5207917 5252353 5252354 5303914 5303916 5626912 904732 / A7OA43 908057 / A7PA10 909551 / A7PA20 910819 / A7PA30 T100870 T104992 T108114 T114599 T938508 T939338 T939640 T942069 T945414 T946497 T949375 T954443 T958062 T963371 T968151 T968381 T972086 T974174 T974550 T977901 T980418 T980555 T983069 T984285 T987813 T993091 T996572 T999967 5001182 5001183 5042920 5042921 5042922 5042923 5056851 5087081 5087082 5109324 5109325 5109326 5109327 5162012 5207918 5252394 5256421 5256479 5256480 5305758 5305759 5305760 5877095 6040220 6040225 6040226 6056133 6056134 903786 / A7OA37 904731 / A7OA43 908058 / A7PA10 909552 / A7PA20 910911 / A7PA31 T100871 T104993 T108115 T114598 T932954 T935264 T939339 T945413 T946498 T947785 T954444 T958061 T963372 T968152 T974175 T977904 T980511 T983070 T984228 T987809 T989000 T993092 T996565 T999969   
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		 Potential for micropores to form, allowing fluid to enter the hollow handle.
FDA Determined
Cause 2		 Process control
Action Urgent recall letters, dated July 29,2015, were sent to end users and sales consultants to inform them of the issue, potential risks, and to provide instructions for returning affected devices and the response form.
Quantity in Commerce 1113
Distribution Nationwide and internationally, including Canada
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.
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