Recall Z-0733-2019 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Waldemar Link GmbH & Co. KG (Mfg Site)
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 ST
| Date | Dec 7, 2018 |
| Status | Terminated |
| Reason | 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. |
| Root 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 | 11 |
| Distribution | US Nationwide in the states of: FL, GA, IA, IN, KS, MI, MN, and TN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142187 | LINK MP RECONSTRUCTION PROSTHESIS Waldemar Link GmbH & Co. KG, Nov 6, 2014 |