Class 2 Device Recall LINK STEM with Microporous Surface MP Reconstruction Prosthesis

• Date Initiated by Firm: December 07, 2018
• Create Date: January 14, 2019
• Recall Status: Terminated on December 17, 2019
• Recall Number: Z-0733-2019
• Recall Event ID: 81778
• 510(K)Number: K142187
• Product Classification: Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented - Product Code LZO
• Product: LINK STEM with Microporous Surface MP Reconstruction Prosthesis, CEMENTLESS (Size XS-0, D: 12mm, L: 160mm), Reference Number 172-916/12 Product Usage: The LINK STEM with Microporous Surface MP Reconstruction Prosthesis, CEMENTLESS System is indicated for patients with mobility-limiting diseases, fractures or defects which cannot be treated by conservative or osteosynthetic procedures. The LINK STEM with Microporous Surface MP Reconstruction Prosthesis, CEMENTLESS System is indicated for the following conditions: Revision arthroplasty due to juxta-articular bone defects Revision of loosened femoral prosthesis components involving extensive bone resorption of the proximal femur and widening of the medullary cavity or marked thinning of proximal femoral cortical bone Revision of loosened femoral prosthesis components with periprosthetic/subprosthetic fracture Deformed proximal femur due to fractures or osteotomies Correction of bone deficiencies, e.g. due to tumors Large post-revision and post-trauma segmental bone defects Oncological and revision surgery from tibial to hip area (in conjunction with Endo-Model SL Rotational and Hinge Knee Prostheses) The device is intended for cemented and cementless use.
• Code Information: Lot numbers: 1435077 1515029 1718103 1435077 150401/0217 1734168 1726056 1718103 1734168 1515029
• Recalling Firm/ Manufacturer: Waldemar Link GmbH & Co. KG (Mfg Site); Oststr. 4-10; Norderstedt Germany
• For Additional Information Contact: Len Tokish; 201-694-7331
• Manufacturer Reason for Recall: The reaming guide and the guide rod can't be screwed into the intended depth. The reason for this is a reduced depth of the core hole in the stem. A reaming guide that is not screwed in completely may lead to a proximal preparation in the depth that is not sufficient and to a neck that can't be positioned correctly. The correct fit of the neck can't be verified by means of the guide rod.
• FDA Determined Cause: Under Investigation by firm
• Action: Urgent Medical Device Recall notification letters dated 12/7/18 were distributed to customers. Please identify your total inventory for this product. Please take the following actions: 1) Immediately cease use and segregate the above described product. 2) Complete the enclosed Consignee Reply Form, even if you have no inventory. 3) Return the above product and a copy of the Consignee Reply Form using Federal Express Account #: 007183879 to: LinkBio Corporation 101 Roundhill Drive Rockaway, NJ 07446 ATT: Nikhil Mangale Recall Return Authorization #: R-2018-03
• Quantity in Commerce: 11
• Distribution: US Nationwide in the states of: FL, GA, IA, IN, KS, MI, MN, and TN.
• 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 = LZO