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U.S. Department of Health and Human Services

Class 2 Device Recall Synthes Flex Arm

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 Class 2 Device Recall Synthes Flex Armsee related information
Date Initiated by FirmMarch 05, 2018
Create DateApril 24, 2018
Recall Status1 Terminated 3 on October 16, 2019
Recall NumberZ-1511-2018
Recall Event ID 79763
Product Classification Orthopedic manual surgical instrument - Product Code LXH
ProductFlex Arm Product Usage: The Synthes Flex Arm is a component of the Synthes Minimally Invasive Support System, which provides secure table mounting for minimally invasive spine surgery. The Flex Arm is designed to hold Synthes Minimally Invasive Retractors, which are connected to the Flex Arm by adapters.
Code Information Lot numbers  9833185, 9866629, 9888308, 9914323, 9940637, 9982802, H044106, H072780, H144265, H212060, H260544, H260547, H305886, H347867, H430221, H430230
Recalling Firm/
Manufacturer		 Synthes, Inc.
1302 Wrights Ln E
West Chester PA 19380-3417
For Additional Information Contact
610-719-5000
Manufacturer Reason
for Recall		Quick connect feature of instruments may be unable to connect to the male features of Flex Arm Adaptors, Insight Retractors, or other mating parts.
FDA Determined
Cause 2		Device Design
ActionThe firm sent an Urgent Product Recall letter dated March 21, 2018, to affected customers. The letter identified the affected product, problem and actions to be taken. For questions call 1-610-719-5450 or contact your DePuy Synthes Sales Consultant.
Quantity in Commerce84
DistributionWorldwide distribution - US Nationwide and the countries of Canada, Switzerland and Japan
Total Product Life CycleTPLC 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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