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Waldemar Link GmbH & Co. KG (Mfg Site) Recall 92758

Description: LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 25 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-25/00

Waldemar Link GmbH & Co. KG (Mfg Site) Recall 92758 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-2356-2023
Event ID92758
Event DescriptionLINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 25 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-25/00
Product TypeDevices
DistributionUS Nationwide distribution.
Quantity24 units
Recall ReasonIncreased 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
Device Classification20230816
Device Code InfoUDI-DI: 04026575182190 Lot Numbers: B922113 B934176 C005048 C211019 C240050
Center Classification Date20230804
Recall Initiation Date20230703
Recalling FirmWaldemar Link GmbH & Co. KG (Mfg Site)
Initial Notification E-Mail
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