Agency classClass IIOur severity:High FDA (Devices)·Z-2348-2023·Announced 2023-08-16

Medical Device Recall: LINK MP Hip Stem Trial Instruments Removal Difficulty Risk

Waldemar Link GmbH recalls LINK MP Monoblock hip stem trial instruments due to increased removal force requirements after impaction, which may prolong surgery or require procedural modification.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This Class II FDA recall involves a potential surgical complication—difficult instrument removal requiring increased force—that could prolong surgery or require procedural modification. No hospitalizations, injuries, or deaths are reported in the source, making this a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Waldemar Link GmbH & Co. KG is recalling the LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 17 (UDI-DI: 04026575182114). The affected units include items with Lot Numbers B922124, B932051, C005064, and C211011, totaling 24 units distributed nationwide in the United States.

The LINK MP trial hip stems are surgical instruments indicated for patients with mobility-limiting diseases or fractures or defects of the hip joint or proximal femur. The recalled instruments may require increased force to remove after impaction, which could prolong the surgical procedure or necessitate modification of the surgical approach.

Healthcare facilities and surgical centers that have received the affected lot numbers should verify their inventory and prepare for potential impacts on scheduled orthopedic procedures. Surgeons performing hip replacement procedures using these trial instruments should be aware of the potential for difficult removal and adjust their surgical planning accordingly.

The recalled product

Product: LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 17 - indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-117/00
Manufacturer: Waldemar Link GmbH & Co. KG (Mfg Site)
Category: Medical Device — Orthopedic / Hip Replacement
Hazard: removal-difficulty
surgical-complication
prolonged-surgery
Affected units: 24

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

UDI-DI: 04026575182114 Lot Numbers: B922124 B932051 C005064 C211011

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 12 recalled by Waldemar Link GmbH & Co. KG (Mfg Site) under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 12 products in this recall →

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