Recall Z-0769-2025 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Waldemar Link GmbH & Co. KG (Mfg Site)
LINK MP Reconstruction System Neck Segment (with suture holes, standard, uncemented, L= 35 mm, CCD 126, Offset= 31 mm, Ti6Al4V, PoroLink, Taper 12/14. Item Number: 99-0984/32 Intended for revision hip arthroplasty in patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck, or portions of the proximal
| Date | Dec 26, 2024 (initiated Dec 5, 2024) |
| Status | Open, Classified |
| Reason | Error on the main label and the patient label. The labels indicate a size XXL, this is a standard-size neck segment.. All further information on the labels is correct (Length, CCD and Offset). |
| Root cause | Under Investigation by firm |
| Action | Link Bio Corp. Dover, NJ issued Urgent Medical Device Recall to Consignees via email on December 5, 2024. Letter states reason for recall, health risk and action to take: Please respond using the attached Distributor Reply form to indicate your understanding of this Device Recall and of the need to return the affected product. Please return the product as soon as possible to the following address: LinkBio Corporation 69 King St Dover, NJ 07801 Please contact LinkBio at 973-625-1333 or complaints@linkbio.com for any questions. |
| Quantity | 3 units |
| Distribution | US Nationwide distribution in the states of AL, FL. |
| 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 |