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U.S. Department of Health and Human Services

Class 2 Device Recall METS

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 Class 2 Device Recall METSsee related information
Date Initiated by FirmDecember 07, 2016
Date PostedDecember 19, 2016
Recall Status1 Terminated 3 on July 17, 2017
Recall NumberZ-0824-2017
Recall Event ID 75892
510(K)NumberK120992 
Product Classification Prosthesis, knee, femorotibial, constrained, cemented, metal/polymer - Product Code KRO
ProductDF Coated Integral Shaft & Stem 15x30x38; DF Coated Integral Shaft & Stem 15x36x44; DF Coated Integral Shaft & Stem 30x30x38; DF Coated Integral Shaft & Stem 30x36x44 The product is a component is a systems that is intended for the replacement if diseased or deficient bone around the knee joint, distal femur, proximal femur or total femur bone
Code Information B10586, B11126, B9875, B9946, B10751, B11513, B9874, B10602, B9876 
Recalling Firm/
Manufacturer		 Stanmore Implants Worldwide Ltd.
210 Centennial Avenue Centennial Park
Centennial Park
Borehamwood United Kingdom
Manufacturer Reason
for Recall		The recalling firm has received 5 customer inquiries reporting that at least one pouch of the double pouch packaging configuration has been punctured by the tip of the device's stem.
FDA Determined
Cause 2		Packaging
ActionStanmore Implants sent an Urgent Field Safety Notice dated November 25, 2016, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to immediately check their internal inventory and quarantine all subject devices, circulate the Field Safety Notice internally to all interested/affected parties, maintain awareness of the notice internally until all required actions have been completed within their facility, inform Stanmore Implants if any of the subject devices have been distributed to other organizations, complete the attached customer response form and list of affected batches form, return the completed form and any affected devices to their S/W Representative. Customers with questions were instructed to contact their local sales representative.
Quantity in Commerce15 units
DistributionNationwide Distribution to OH, NE, FL, LA, NY, TX, MS, MD, CT, AL, PA
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 = KRO
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