Agency classClass IIOur severity:High FDA (Devices)·Z-2355-2023·Announced 2023-08-16

LINK MP Hip Stem Trial Instruments difficult to remove after implantation

The LINK MP Monoblock hip stem trial instruments may require increased force to remove after implantation, potentially prolonging surgery or requiring modification of the surgical procedure.

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 recall involving potential intraoperative complications (prolonged surgery or procedure modification) due to device removal difficulty. No patient injuries or adverse outcomes reported.

Plain-English summary

The LINK MP Monoblock hip stem trial instruments are subject to recall due to difficulty in device removal after surgical implantation. Increased force may be required to remove the devices following implantation, potentially causing prolonged surgery or requiring modification of the surgical procedure.

The recall affects trial stem instruments in sizes 14mm through 25mm, with distribution throughout the United States. The devices are indicated for patients with mobility-limiting diseases, fractures, or defects of the hip joint or proximal femur. Affected lot numbers include B922115, B933170, C005042, C211018, and C240049 (UDI-DI: 04026575182183, Size 24).

This is an FDA Class II recall issued by manufacturer Waldemar Link GmbH & Co. KG.

The recalled product

Product: LINK 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
Manufacturer: Waldemar Link GmbH & Co. KG (Mfg Site)
Category: Medical Device — Orthopedic Implant
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: 04026575182183 Lot Numbers: B922115 B933170 C005042 C211018 C240049

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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Same hazard · difficult removal