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.
- Recall Initiated
- December 7, 2018
- Terminated
- December 17, 2019
- Recall Number
- Z-0733-2019
- Quantity
- 11
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.
Distribution
US Nationwide in the states of: FL, GA, IA, IN, KS, MI, MN, and TN.
Lot / Code Info
Lot numbers: 1435077 1515029 1718103 1435077 150401/0217 1734168 1726056 1718103 1734168 1515029
Root Cause
Under Investigation by firm
Action Taken
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