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U.S. Department of Health and Human Services

Class 2 Device Recall Synthes

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 Class 2 Recall
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Date Posted February 20, 2014
Recall Status1 Open
Recall Number Z-1057-2014
Recall Event ID 67261
Product Classification Orthopedic Manual Surgical Instrument - Product Code LXH
Product Synthes Driving Cap/Threaded Both parts are intended for use in the Tibia system, LFN and RAFN systems. Their function is to insert a nail. The Synthes Driving Cap/Threaded is threaded into the insertion handle and secured with a wrench. If desired, the nail can then be inserted using light hammer blows.
Code Information Part No. 03.010.523, Lot Nos. 8279162 & 8429004
Recalling Firm/
Synthes, Inc.
1302 Wrights Ln E
West Chester, Pennsylvania 19380-3417
For Additional Information Contact Customer Support
Manufacturer Reason
for Recall
The Synthes Driving Cap/Threaded can bind in the IM Nail Radiolucent Insertion Handles when assembled becoming difficult to separate.
Action Synthes sent an Urgent Notice - Medical Device Recall Letter dated January 7 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. Action to be taken: Our records indicate that your facility has the product(s) subject to this Recall. Synthes asks that you review your inventory and immediately remove the affected lots from stock. Please take the following actions: If you DO have any of the identified devices, please take the following steps: "Call DePuy Synthes at 1-800-479-6329 to obtain a Return Authorization Number. "Complete the Verification Section at the end of this letter by checking the appropriate box indicating affected product has been located. Also, please indicate the number of devices found and note the Return Authorization Number. Please include your name, title, telephone number and signature in the spaces provided. "Return the Verification Form (page-3 of this letter) with the product to: "Credit/Returns, Synthes, 1101 Synthes Avenue, Monument, CO 80132. If you DO NOT have the identified product, please take the following steps: "Complete the attached Verification Section at the end of this letter by checking the appropriate box indication that no affected product has been located. :Please include your name, title, telephone number and signature in the spaces provided this return documentation acknowledges your receipt of medical device removal information. "Return the documents to DePuy Synthes by: " Fax: 877-271-1473 or " Scan/email: FieldAction@synthes.com If you have any questions,please call 610-719-5450. Thank you for your attention to this issue.
Quantity in Commerce 143
Distribution USA (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