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U.S. Department of Health and Human Services

Class 2 Device Recall Synthes Threaded Plate Holder Long for 3.5mm Locking Hold

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  Class 2 Device Recall Synthes Threaded Plate Holder Long for 3.5mm Locking Hold see related information
Date Initiated by Firm October 07, 2015
Create Date October 30, 2015
Recall Status1 Terminated 3 on August 26, 2016
Recall Number Z-0192-2016
Recall Event ID 72360
Product Classification Mesh, surgical, metal - Product Code EZX
Product Synthes Threaded Plate Holder- Long for 3.5mm Locking Hold; Part Numbers 324.031.

The Threaded Plate Holder can be used as an aid to position the plate on the bone. The plate holder may also function as an insertion handle for use with minimally invasive plating techniques. The plate may be temporarily held in place with standard plate holding forceps or the push-pull reduction device.
Code Information Threaded Plate Holder-Long for 3.5mm Locking Hole  Part Numbers Lot Numbers  324.031 8225613 
Recalling Firm/
Manufacturer		 Synthes (USA) Products LLC
1301 Goshen Pkwy
West Chester PA 19380-5986
For Additional Information Contact
610-719-6500
Manufacturer Reason
for Recall		 The affected part number and lot listed above is incorrectly etched with the wrong part number and may not fit into a Small Fragment Plate.
FDA Determined
Cause 2		 Mixed-up of materials/components
Action The firm, DePuy Synthes, sent an "URGENT NOTICE: MEDICAL DEVICE RECALL" letter dated 10/5/2015 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: " Call DePuy Synthes at 1-800-479-6329 to obtain a Return Authorization (RA) Number and replacement product(s). " Complete the Verification Section (page 3 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, address, telephone number and signature in the spaces provided. " Return the Verification Section (page 3 of this letter) with the product to: Credit/Returns, DePuy Synthes, 1101 Synthes Avenue, Monument, CO 80132. Even if you do not have any product. " Send a copy of the completed Verification Section by: Fax: 844-721-3048 or Scan/email: Synthes4704@stericycle.com. " Note: If the Verification Section is answered on behalf of more than one facility and/or individual, please clearly indicate the name and address of the facility and/or individual on page 3 of the notification. If you have any questions, please call 610-719-5450 or contact your DePuy Synthes Sales Consultant.
Quantity in Commerce 25
Distribution Worldwide distribution: US (nationwide) and country of: 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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