PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: August 16, 2023 Initiated: July 3, 2023 #Z-2352-2023

Product Description

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

Reason for Recall

Increased 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

Details

Units Affected
24 units
Distribution
US Nationwide distribution.
Location
Norderstedt, N/A

Frequently Asked Questions

What product was recalled?
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. Recalled by Waldemar Link GmbH & Co. KG (Mfg Site). Units affected: 24 units.
Why was this product recalled?
Increased 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
Which agency issued this recall?
This recall was issued by the FDA Devices on August 16, 2023. Severity: Moderate. Recall number: Z-2352-2023.