Recall Z-2345-2023 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Waldemar Link GmbH & Co. KG (Mfg Site)
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 14-Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur. Item Number: 136-114/00
| Date | Aug 4, 2023 (initiated Jul 3, 2023) |
| Status | Open, Classified |
| Reason | Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modified due to this issue |
| Root cause | Device Design |
| Action | LinkBio Corp initiated Urgent Medical Device Recall Letter to US Distributors via email on July 6, 2023. 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. These trials are contained in the MP Monoblock instrument sets. The entire instrument set must be returned as part of this recall. Pre-paid shipping labels will be provided once the Distributor Reply Form is returned. Please return the product as soon as possible to the f |
| Quantity | 14 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K183141 | LINK MP Monoblock Hip Prosthesis Waldemar Link GmbH & Co. KG, Feb 8, 2019 |