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Recall

Class II — Waldemar Link GmbH & Co. KG (Mfg Site)

Recalling firmWALDEMAR LINK GMBH & CO. KG
Registered facilityWaldemar Link GmbH & Co. KG (the firm's only registered facility)
ClassificationClass II
StatusOngoing
ReasonIncreased 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
ProductLINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 24 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-24/00
Quantity24 units
DistributionUS Nationwide distribution.
Initiated2023-07-03
Classified2023-08-04
Recall numberZ-2355-2023
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Waldemar Link GmbH & Co. KG (Mfg Site) (Z-2355-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/92758/

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