Recall Z-0729-2019 · MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Waldemar Link GmbH & Co. KG (Mfg Site)
BiMobile UHMWPE Liner: ID-28mm/OD-54mm, Reference Number 184-260/04 The LINK BiMobile Dual Mobility System is indicated for patients with mobility-limiting diseases, fractures or defects which cannot be treated by conservative or osteosynthetic procedures. The device is intended for cemented and cementless use.
| Date | Dec 4, 2018 |
| Status | Terminated |
| Reason | The internal labeling included with these implants may include incorrect part numbers and could result in these incorrect labels being added to patient records. |
| Root cause | Employee error |
| Action | The firm, LinkBio Corp., Sent an "URGENT MEDICAL DEVICE RECALL" letter dated 12/4/2018 to its customers. The letter describes the product, problem and actions to be taken. The customers are instructed to do the following: Please identify your total inventory for this product. 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 Reca |
| Quantity | 31 |
| Distribution | US distribution to states of: AZ, FL, GA, LA, MI, MN, TX, and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K171273 | LINK® BiMobile(TM) Dual Mobility System Waldemar Link GmbH & Co. KG, Jan 19, 2018 |