Recall Z-1219-2024 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Waldemar Link GmbH & Co. KG (Mfg Site)
LINK BiMobile Dual Mobility System E-Poly Liner for 28mm Head, 70mm Shell- Indicated for patients with mobility-limiting diseases, fractures or defects of the hip joint or proximal femur. Item Number: 184-280/12
| Date | Feb 29, 2024 (initiated Jan 22, 2024) |
| Status | Open, Classified |
| Reason | Mislabeled: Packaging incorrectly reflects a MobileLink Dual Mobility insert type F when it should reference G may cause a delay in surgery |
| Root cause | Under Investigation by firm |
| Action | LinkBio Corp issued Urgent: Medical Device Recall letter via email on 1/22/24 to Distributors. 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. Pre-paid shipping labels will be provided once the Distributor Reply Form is returned. 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 qu |
| Distribution | Worldwide - US Nationwide distribution in the states of IL, IN, FL, WA and the countries of Germany, Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K190535 | BiMobile Dual Mobility System - E-Dur Inserts Waldemar Link GmbH & Co. KG, Aug 6, 2019 |