LINK BiMobile Dual Mobility System E-Poly Liner for 28mm Head, 70mm Shell- Indicated for patients with mobility-limiting
FDA device recall Z-1219-2024 · posted 2024-02-29 · Open, Classified
Recall details
- Recalling firm
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Reason for recall
- Mislabeled: Packaging incorrectly reflects a MobileLink Dual Mobility insert type F when it should reference G may cause a delay in surgery
- Action taken
- 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 questions.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- LZO
- Distribution
- Worldwide - US Nationwide distribution in the states of IL, IN, FL, WA and the countries of Germany, Switzerland.
- Date initiated
- 2024-01-22
- Date posted
- 2024-02-29
- Location
- Norderstedt, Germany
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BiMobile Dual Mobility System - E-Dur Inserts (K190535) | Waldemar Link GmbH & Co. KG | 2019-08-06 |