Waldemar Link GmbH & Co. KG (Mfg Site) recalls Tibial Component Modular. orthopedic prosthesis. Model Nos: Small, W 16-2817/32 Medium, W 16-2817/35 Large, W 16-2817/37
There is a risk that blind screws of the modular tibial component cannot be loosened intraoperatively. This may lead to prolongation of surgery due to an intraoperative change in procedure.
Read the official notice →- Date
- 2022-07-20
- Country
- United States
- Brand
- Waldemar Link GmbH & Co. KG
- Product
- Tibial Component Modular. orthopedic prosthesis. Model Nos: Small, W 16-2817/32 Medium, W 16-2817/35 Large, W 16-2817/37
- Classification
- Class II
- Units
- Domestic distribution to AL, CA, FL, GA, IL, IN, KS, MI, MN, NV, NY, OH, TN,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2024-01-24
USWaldemar 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…
FDA · DeviceWaldemar Link GmbH & Co. KG (Mfg Site)US Nationwide distribution in the state of NH.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…
- 2023-07-12
- US
Waldemar Link GmbH & Co. KG (Mfg Site) recalls LinkSymphoKnee Distal Femoral Augment - Tilastan - Size. 7-8, Lateral-Right/Medial-Left, 5mm-Intended for primary and…
Fixation screw was inserted through the wrong side of the augment (distal to proximal, as opposed to proximal to distal, which is the correct orientation).
FDA · DeviceWaldemar Link GmbH & Co. KG (Mfg Site)US Nationwide distribution in the states of AL, IL, IN, LA, GA, NV, TX.Official notice → - 2023-07-05
- US
Waldemar Link GmbH & Co. KG (Mfg Site) recalls LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Left
The firm discovered through customer complaints that device segments may not meet specifications.
FDA · DeviceWaldemar Link GmbH & Co. KG (Mfg Site)Domestic: AL, GA, IL, IN, KS, NJ, NY, and TX. Foreign: Argentina, Australia,…Official notice →
Other drugs & medical recalls in the United States
- 2022-07-20
- US
Aesculap Implant Systems LLC recalls AESCULAP TC COOELY MICRO NEEDLEHLDER SERR 200MM, product code MG524R. manual surgical instrument designed to grasp a suture needle
Needleholder incorrectly labeled as 200MM when the actual instrument size is 150MM.
- US
Breas Medical, Inc. recalls Vivo 45LS Ventilator- intended to provide continuous or intermittent ventilatory support for the care of individuals who require…
A forced shutdown of one of the processors did not generate a watch dog alarm, would develop into a failure AND the instructions to monitor a ventilator dependent patient are NOT followed, the health consequences could…
- US
Ivenix, Inc. recalls Ivenix Infusion System (IIS)
Downstream occlusion alarm is sometimes immediately followed by a pump problem alarm.
- US
DePuy Orthopaedics, Inc. recalls MODULAR CATHCART FRACTURE HEAD HIP BALL, sizes 41mm to 60mm inclusive; metallic femoral head prosthesis, Product No. 136341000,…
The Cathcart Ball has an inherent +5mm offset which is not currently specified in its Instructions for Use or Surgical Technique Guide. The STG has been updated to reflect the clarification that the +5mm offset should…
FDA · DeviceDePuy Orthopaedics, Inc.Worldwide distribution - US Nationwide and the countries of Australia,…Official notice → - US
Ventana Medical Systems Inc recalls Ventana HE 600 System, automated slide preparer, for use in laboratories.
There is a potential for fluid leak inside the Ventana HE 600 instrument which could result in electrical short and fire
FDA · DeviceVentana Medical Systems IncUS: AL AR AZ CA CO CT DC FL GA HI IA IL IN KS KY MA MD MI MN MO MS MT NC NE NJ…Official notice → - US
Alcon Research, LLC recalls Alcon Custom Pak Surgical Procedure Pack: 16998-11 2519351H SALAHUDDIN 2.4 PACK FRESNO SURGICAL HOSP 18392-03 14HDFF CATARACT SWAGEL…
Due to latex gloves being include in Custom Pak. Kits are supposed to include non-latex gloves.