FDA (Devices) recall action 92758

Waldemar Link GmbH & Co. KG (Mfg Site) recalled 12 products on 2023-08-16

The FDA (Devices) publishes a recall like this one as 12 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 12 pages.

Products: 12
Announced: 2023-08-16
Critical: 0
Units: 278

Why these products were 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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–12 of 12

ModerateFDA (Devices)··2023-08-16
LINK MP Hip Stem Difficult to Remove After Surgical Implantation
Waldemar Link is recalling LINK MP Monoblock hip stem prosthetics that may require increased force to remove after surgical implantation, potentially prolonging surgery.
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
Category
Distribution
0 states
HighFDA (Devices)··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.
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
Category
Distribution
0 states
HighFDA (Devices)··2023-08-16
LINK MP Monoblock Hip Stem trial instruments recalled for increased removal difficulty
Waldemar Link GmbH recalled LINK MP Monoblock hip stem trial instruments (Size 23) nationwide due to increased force required for removal post-impaction, potentially prolonging surgery time.
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
Category
Distribution
0 states
HighFDA (Devices)··2023-08-16
Hip implant trial stem: increased removal force may extend surgery
Waldemar Link is recalling LINK MP Monoblock Hip Stem trial instruments due to increased force required for removal during surgery, which may prolong the procedure or require modification.
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
Category
Distribution
0 states
HighFDA (Devices)··2023-08-16
LINK MP Monoblock Hip Stem Trial Instruments May Require Increased Removal Force
LINK MP Monoblock Hip Stem trial instruments may require increased force to remove after impaction, potentially prolonging surgery for affected patients.
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
Category
Distribution
0 states
HighFDA (Devices)··2023-08-16
LINK MP Monoblock Hip Stem Trial Instruments Difficult to Remove After Impaction
Waldemar Link is recalling LINK MP Monoblock Hip Stem trial instruments because they may require increased force to remove after impaction, potentially prolonging surgery or requiring procedural modification.
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
Category
Distribution
0 states
HighFDA (Devices)··2023-08-16
Medical Device Recall: LINK MP Hip Stem Trial Instruments Removal Difficulty Risk
Waldemar Link GmbH recalls LINK MP Monoblock hip stem trial instruments due to increased removal force requirements after impaction, which may prolong surgery or require procedural modification.
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
Category
Distribution
0 states
HighFDA (Devices)··2023-08-16
Hip Stem Trial Implant May Require Excessive Force During Removal
A trial hip stem implant may require excessive force to remove after insertion during surgery, potentially prolonging the procedure or requiring surgical modification.
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
Category
Distribution
0 states
HighFDA (Devices)··2023-08-16
LINK MP Monoblock Hip Stem trial instruments recalled for difficulty in removal
Waldemar Link is recalling 24 LINK MP Monoblock Hip Stem trial instruments due to increased force required to remove them after impaction, which may prolong surgery or require procedure modification.
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
Category
Distribution
0 states
HighFDA (Devices)··2023-08-16
Hip stem trial instruments recalled due to excessive removal force
LINK MP Monoblock hip stem trial instruments may require excessive force to remove after impaction, potentially prolonging surgery or requiring procedural modification.
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
Category
Distribution
0 states
HighFDA (Devices)··2023-08-16
LINK MP Hip Stem trial instruments may require increased removal force during surgery
LINK MP Monoblock hip stem trial instruments may require increased force to remove during surgery, potentially prolonging procedures or requiring surgical modification.
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
Category
Distribution
0 states
ModerateFDA (Devices)··2023-08-16
Hip Stem Trial Instrument Difficult to Remove After Impaction
LINK MP Monoblock hip stem trial instruments may require increased force to remove after impaction, potentially prolonging surgery or requiring procedure modification. No injuries or illnesses have been reported.
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
Category
Distribution
0 states