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U.S. Department of Health and Human Services

Class 2 Device Recall Periarticular Insertion Handle and Periarticular Aiming Arm for 4.5mm LCP Proximal Tibia Plates

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 Class 2 Device Recall Periarticular Insertion Handle and Periarticular Aiming Arm for 4.5mm LCP Proximal Tibia Platessee related information
Date Initiated by FirmSeptember 14, 2015
Date PostedOctober 05, 2015
Recall Status1 Terminated 3 on July 15, 2016
Recall NumberZ-0024-2016
Recall Event ID 72238
Product Classification Orthopedic manual surgical instrument - Product Code LXH
ProductSynthes Periarticular Insertion Handle for 4.5mm LCP Proximal Tibia Plates and Periarticular Aiming Arm for 4.5mm LCP Proximal Tibia Plates
Code Information Part Numbers: 03.120.005 03.120.004 03.120.002 03.120.001 with Lot Numbers: 1780076; 1797331; 1829300 1789754; 1802319; 1810706; 1810707; 5704446 1780074; 1829294; 1829296 1789751; 1802318; 1810704; 1810705; 1828749; 1879604 
FEI Number 3008812560
Recalling Firm/
Manufacturer		 Synthes (USA) Products LLC
1301 Goshen Pkwy
West Chester PA 19380-5986
For Additional Information ContactCustomer Support
610-719-6500
Manufacturer Reason
for Recall		Affected lots of Periarticular Aiming Arms and Insertion Handles (Part Numbers 03.120.001, 03.120.002, 03.120.004 and 03.120.005) for the 4.5 mm LCP Proximal Tibia Plates are not able to be secured to the subsequent versions of these devices as intended.
FDA Determined
Cause 2		Device Design
ActionAn urgent notice of medical device recall, dated September 14, 2015, was sent to end users and sales consultants to alert them to the issue and potential risks. Return of the completed response form and the affected devide was also requested.
Quantity in Commerce172
DistributionNationally
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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