FDA recall Z-2347-2023

Product

LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 16 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-116/00

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

Distribution

US Nationwide distribution.

Key facts

Status

Ongoing

Initiation date

2023-07-03

Report date

2023-08-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Norderstedt, N/A, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2347-2023