Waldemar Link GmbH & Co. KG (Mfg Site) recalls Link Patella Glide Resection Guide- For the implantation of the Endo-Model Knee System as part of a total knee…
Mislabeled: Angle and height of the device marked as L(large) corresponds to the small/medium dimensions due to a product mix-up. This may result in too little bone material resected and not fit correctly leading to…
Read the official notice →- Date
- 2024-01-24
- Country
- United States
- Brand
- Waldemar Link GmbH & Co. KG
- Product
- Link Patella Glide Resection Guide- For the implantation of the Endo-Model Knee System as part of a total knee arthroplasty procedure.…
- Classification
- Class II
- Units
- US Nationwide distribution in the state of NH.
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Waldemar Link GmbH & Co. KG recalls
- 2024-03-20
USWaldemar Link GmbH & Co. KG (Mfg Site) recalls SPII Model Lubinus, Long Stem Prosthesis XL Neck, cemented
Due to two complaints, has come to our attention that additional guidance is required on the correct interpretation of the carton label Size and Type columns to avoid misinterpretation during surgery.
FDA · DeviceWaldemar Link GmbH & Co. KG (Mfg Site)US Nationwide distribution in the states of AL, AZ, CA, FL, GA, ID, IL, IN,…Official notice →- 2024-03-13
- US
Waldemar Link GmbH & Co. KG (Mfg Site) recalls Embrace Drill Tower, Wedged (25mm)
The surgical techniques for the Embrace Shoulder Instruments -Drill Tower (Article REF 645-081/62 & /63) have mixed-up type descriptions ("standard" vs "wedged") in the overview of the instruments.
FDA · DeviceWaldemar Link GmbH & Co. KG (Mfg Site)US Nationwide distribution in the states of AL and LA.Official notice → - 2024-03-06
- US
Waldemar Link GmbH & Co. KG (Mfg Site) recalls LINK BiMobile Dual Mobility System E-Poly Liner for 28mm Head, 70mm Shell- Indicated for patients with mobility-limiting…
Mislabeled: Packaging incorrectly reflects a MobileLink Dual Mobility insert type F when it should reference G may cause a delay in surgery
FDA · DeviceWaldemar Link GmbH & Co. KG (Mfg Site)Worldwide - US Nationwide distribution in the states of IL, IN, FL, WA and the…Official notice → - 2023-10-04
- US
Waldemar Link GmbH & Co. KG (Mfg Site) recalls MobileLink Acetabular Cup System, Shell/Insert Adapter for Shell 74-80mm, Insert Size F, +12mm Offset 20 degrees…
Product is labeled with incorrect offset.
FDA · DeviceWaldemar Link GmbH & Co. KG (Mfg Site)Domestic distribution to AL, NJ, NV.Official notice → - 2023-09-06
- US
Waldemar Link GmbH & Co. KG (Mfg Site) recalls Link OptiStem Rasp Handle-Used with the OptiStem Rasp to prepare the femoral medullary canal for a knee prosthesis…
A crack in the weld of the rasp handle may lead to a fracture of the frontal sleeve when the rasp is further impacted or extracted. The rasp remains intact. The rasp would need to be pulled out by a clamp leading to a…
- 2023-08-16
- US
Waldemar Link GmbH & Co. KG (Mfg Site) recalls LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 17 - indicated for patients with Mobility-limiting diseases,…
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…
Other drugs & medical recalls in the United States
- 2024-01-24
- US
Randox Laboratories Ltd. recalls Calibration Serum Level 3 CAL2351
CK Total in Calibration Serum Level 3, CAL2351, is running with a positive bias on RX Series instruments compared to other methods experience a shift in Quality Control and patient sample recovery of up to 13%.
- US
Randox Laboratories Ltd. recalls Calibration Serum Level 3. CAL 3, REF CAL2351. Human Assayed Multi-Sera Level 2 (HN1530) Human Assayed Multi-Sera Level 3 (HE 1532)
There have been transcription errors on the Instructions For Use (IFU) of the Calibration Serum Level 3 (CAL2351 lot 1260UE, 1262UE and 1315UE) for target values of Bilirubin and Triglycerides, on the IFU of Human…
- US
Xcision Medical Systems, LLC recalls GammaPod - Treatment Planning System-a component of the GammaPod Irradiation System. Ref: XMSGP030A09.07-0.01 Intended for use in…
Wrong structures imported into the GammaPod Treatment Planning System.-system allowed an RTSS generated from a previous CT scan to be selected
FDA · DeviceXcision Medical Systems, LLCWorldwide - US Nationwide distribution in the states of MD, PA, TX and the…Official notice → - US
Olympus Corporation of the Americas recalls SOLTIVE SuperPulsed Laser Fibers Model Numbers TFL-FBX150S, TFL-FBX200S, TFL-FBX365S, TFL-FBX550S, TFL-FBX940S,…
Olympus identified inconsistencies in the Instructions for Use regarding cleaning the fiber tip and fiber cleaving and stripping instructions. Following the current instructions presents the potential for the fiber to…
FDA · DeviceOlympus Corporation of the AmericasWorldwide distribution - US Nationwide and the countries of Canada, Europe,…Official notice → - US
Smiths Medical Asd Inc recalls 48IN (121.9CM) INJ LINE ROTATING ADAPT (900psi), List Number MX694R
There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during…
FDA · DeviceSmiths Medical Asd IncWorldwide distribution - US Nationwide and the countries of Canada, UAE.Official notice → - US
PHASE SCIENTIFIC INTERNATIONAL LIMITED recalls INDICAID COVID-19 Rapid Antigen At-Home Test, REF: P0040
COVID-19 rapid antigen at home tests were released with an incorrect expiration date of 05 April 2024 when the correct expiration should be 21 February 2024. Expired tests could produce invalid or inaccurate results.
FDA · DevicePHASE SCIENTIFIC INTERNATIONAL LIMITEDUS Nationwide distribution including in the states of CA, NY, VT, WA, OH, MD ,…Official notice →