LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 19-Indicated for patients with Mobility-limiting diseases, frac
FDA device recall Z-2350-2023 · posted 2023-08-04 · Open, Classified
Recall details
- Recalling firm
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Reason for recall
- 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
- Action taken
- 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 following address, referencing QT 2023-238: LinkBio Corporation 69 King St Dover, NJ 07801 Please contact LinkBio at 973-625-1333 or complaints@linkbio.com for any questions
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- LZO
- Quantity affected
- 24 units
- Distribution
- US Nationwide distribution.
- Date initiated
- 2023-07-03
- Date posted
- 2023-08-04
- Location
- Norderstedt, Germany
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LINK MP Monoblock Hip Prosthesis (K183141) | Waldemar Link GmbH & Co. KG | 2019-02-08 |