Agency classClass IIOur severity:High FDA (Devices)·Z-2352-2023·Announced 2023-08-16

LINK MP Hip Stem trial instruments may require increased removal force during surgery

LINK MP Monoblock hip stem trial instruments may require increased force to remove during surgery, potentially prolonging procedures or requiring surgical 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: FDA Class II device with documented operational risk: trial stem instruments may require excessive force to remove during surgery, potentially prolonging procedures or necessitating surgical modification. No injuries or illnesses reported, but the inherent risk of surgical complications qualifies as a risk-of-harm product without reported harm.

Plain-English summary

LINK MP Monoblock Hip Stem Trial Stem Instruments, Size 21 (Item Number 136-121/00) have been recalled by Waldemar Link GmbH & Co. KG. The devices are trial stems used in hip replacement procedures for patients with mobility-limiting diseases, fractures, or defects of the hip joint or proximal femur.

The recall involves 24 units distributed nationwide in the United States with lot numbers B922120, B933167, C005021, and C211015. The issue is that increased force may be required to remove these trial stem instruments after impaction during surgery, which could potentially prolong the surgical procedure or require modification of the surgical technique.

Healthcare providers using these devices should contact Waldemar Link GmbH & Co. KG for additional information and guidance. Patients who have undergone hip replacement surgery using these trial instruments should consult their surgeon if they have concerns about their procedure.

The recalled product

Product: LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 21 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-121/00
Manufacturer: Waldemar Link GmbH & Co. KG (Mfg Site)
Category: Medical Device — Orthopedic / Surgical Instrument
Hazard: removal-difficulty
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: 04026575182152 Lot Numbers: B922120 B933167 C005021 C211015

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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