LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 23 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-23/00
FDA Recall Z-2354-2023 · Posted 2023-08-04
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Recalling FirmWaldemar Link GmbH & Co. KG (Mfg Site)
Recall StatusOpen, Classified
Product CodeLZO
Date Initiated2023-07-03
Product Quantity24 units
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
Firm 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 following address, referencing QT 2023-238:
LinkBio Corporation
69 King St
Dover, NJ 07801
Please contact LinkBio at 973-625-1333 or [email protected] for any questions
Root Cause
Device Design
Distribution Pattern
US Nationwide distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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