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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Waldemar Link GmbH & Co. KG (Mfg Site): 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

Agency Publication Date: August 4, 2023
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Affected Products

Product: LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 14-Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur. Item Number: 136-114/00

UDI-DI: 04026575182084 Lot Numbers: B923005 B932048

Lot Numbers:
Numbers
Product: LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 15 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur. Item Number: 136-115/00

UDI-DI: 04026575182091 Lot Numbers: B923004 B932049 C005089 C211009

Lot Numbers:
Numbers
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

UDI-DI: 04026575182107 Lot Numbers: B923003 B932050 C005075 C211010

Lot Numbers:
Numbers
Product: LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 17 - indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-117/00

UDI-DI: 04026575182114 Lot Numbers: B922124 B932051 C005064 C211011

Lot Numbers:
Numbers
Product: LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 18 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-118/00

UDI-DI: 04026575182121 Lot Numbers: B922123 B932052 C005067 C211012

Lot Numbers:
Numbers
Product: LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 19-Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-119/00

UDI-DI: 04026575182138 Lot Numbers: B922122 B932054 C005071 C211013

Lot Numbers:
Numbers
Product: LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 20 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-120/00

UDI-DI: 04026575182145 Lot Numbers: B922121 B933166 C005012 C211014

Lot Numbers:
Numbers
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

UDI-DI: 04026575182152 Lot Numbers: B922120 B933167 C005021 C211015

Lot Numbers:
Numbers
Product: LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 22 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-22/00

UDI-DI: 04026575182169 Lot Numbers: B922119 B933168 C005032 C211016

Lot Numbers:
Numbers
Product: LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 23 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-23/00

UDI-DI: 04026575182176 Lot Numbers: B922118 B933169 C005023 C211017 C240048

Lot Numbers:
Numbers
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

UDI-DI: 04026575182183 Lot Numbers: B922115 B933170 C005042 C211018 C240049

Lot Numbers:
Numbers
Product: 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

UDI-DI: 04026575182190 Lot Numbers: B922113 B934176 C005048 C211019 C240050

Lot Numbers:
Numbers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 92758
Status: Active
Manufacturer: Waldemar Link GmbH & Co. KG (Mfg Site)
Manufactured In: Germany
Units Affected: 12 products (14 units; 24 units; 24 units; 24 units; 24 units; 24 units; 24 units; 24 units; 24 units; 24 units; 24 units; 24 units)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.