Agency classClass IIOur severity:High FDA (Devices)·Z-2350-2023·Announced 2023-08-16

Hip stem trial instruments recalled due to excessive removal force

LINK MP Monoblock hip stem trial instruments may require excessive force to remove after impaction, potentially prolonging surgery or requiring 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 is a risk-of-harm product where increased removal force may require surgical procedure modification, but no injuries or hospitalizations have been reported. FDA Class II recalls with confirmed harm are scored higher; this represents a procedural risk to surgical patients without documented incidents.

Plain-English summary

The FDA has recalled the LINK MP Monoblock Hip Stem trial instruments (Size 19, Item Number 136-119/00) manufactured by Waldemar Link GmbH & Co. KG. These are surgical instruments used in hip replacement procedures for patients with mobility-limiting diseases, fractures, or defects of the hip joint or proximal femur.

The recall was initiated because increased force may be required to remove the trial hip stem after impaction. This can result in prolonged surgery or the need to modify the surgical procedure.

The affected lot numbers are B922122, B932054, C005071, and C211013. A total of 24 units were distributed nationwide in the United States.

Surgeons using these trial instruments should be prepared for potential difficulties during removal and may need to have backup plans for surgical modification.

The recalled product

Product: LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 19-Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-119/00
Manufacturer: Waldemar Link GmbH & Co. KG (Mfg Site)
Category: Medical Device — Hip Replacement Instruments
Hazard: difficult-removal
surgical-complication
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: 04026575182138 Lot Numbers: B922122 B932054 C005071 C211013

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 →

Same manufacturer · Waldemar Link GmbH & Co. KG (Mfg Site)

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