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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 METS see related information
Date Initiated by Firm December 07, 2016
Date Posted December 19, 2016
Recall Status1 Terminated 3 on July 17, 2017
Recall Number Z-0823-2017
Recall Event ID 75892
510(K)Number K120992  
Product Classification Prosthesis, knee, femorotibial, constrained, cemented, metal/polymer - Product Code KRO
Product Femoral Integral Shaft & Stem 15x27 HA Coated; Femoral Integral Shaft & Stem 15x30 HA Coated; Femoral Integral Shaft & Stem 30x27 HA Coated; Femoral Integral Shaft & Stem 30x30 HA Coated
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 B10635, B11820, B12776, B10636, B10638, B9866 
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
Action Stanmore 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 Commerce 15 units
Distribution Nationwide Distribution to OH, NE, FL, LA, NY, TX, MS, MD, CT, AL, PA
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.
510(K) Database 510(K)s with Product Code = KRO and Original Applicant = STANMORE IMPLANTS WORLDWIDE LTD
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