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U.S. Department of Health and Human Services

Class 2 Device Recall Titanium Single Vector Distractor Body and Proximal Foot Plate

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 Class 2 Device Recall Titanium Single Vector Distractor Body and Proximal Foot Platesee related information
Date Initiated by FirmMay 23, 2016
Create DateAugust 17, 2016
Recall Status1 Terminated 3 on December 13, 2016
Recall NumberZ-2582-2016
Recall Event ID 74419
510(K)NumberK981075 
Product Classification External mandibular fixator and/or distractor - Product Code MQN
ProductTI Single Vector Distractor Body with Left Foot/20mm; Catalog ID 487.963 The Titanium Single Vector Distractor and Proximal Foot Plates are intended for mandibular bone lengthening where gradual bone distraction is required, including conditions such as congenital mandibular deficiencies or post-traumatic defects.
Code Information Part #487.963, Lot # A4JX956; 4038561; 4091230; 4281408; 4294703; 4454536; 4475459; 5041111; 5041112; 5414450; 5414451; 5505099; 5505140; 5621104; 5621108; 5621109; 5621110; 6291848; 6879052; 7626782; 7865438; 9890200; mfg. 09JUN1999 -26APR2016, Exp. 22MAR2020-26APR2036
Recalling Firm/
Manufacturer		 Synthes (USA) Products LLC
1301 Goshen Pkwy
West Chester PA 19380-5986
For Additional Information ContactAnn Brisson
610-719-5443
Manufacturer Reason
for Recall		DePuy Synthes is voluntarily initiating a recall due to a possibility the fastener on the Titanium Single Vector Distractor Body may become prematurely separated from the Proximal Foot Plate.
FDA Determined
Cause 2		Under Investigation by firm
ActionThe firm, DePuy Synthes, mailed out an "URGENT NOTICE: MEDICAL DEVICE RECALL" letter dated 5/23/2016 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to review your inventory and immediately take the following actions: If you DO have any of the identified devices call DePuy Synthes at 1-800-479-6329 to obtain a Return Authorization (RA) Number, complete the Verification Section (page 3 of the letter) indicating the number of devices that were found and return the Verification Section (page 3 of the letter) with the product to the following: Credit/Returns, DePuy Synthes, 1101 Synthes Avenue, Monument, CO 80132, by fax 844-449-8498 or scan/email: Synthes8096@stericycle.com., and complete the Verification section even if you DO NOT have the identified product. Note: If the Verification Section is answered on behalf of more than one facility and/or individual clearly indicate the name and address of the facility and/or individual. If you have any questions, please call 610-719-5450 or contact your DePuy Synthes Sales Consultant.
Quantity in Commerce182 units
DistributionWorldwide Distribution-US (nationwide) distribution to states of: AZ, CA, CO, DC, FL, IL, MA, MI, NJ, NY, PA, TX, UT, WI, and WV; and countries of: Australia, Canada and Switzerland.
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.
510(K) Database510(K)s with Product Code = MQN
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