Conformis, Inc. recalls CONFORMIS HIP-SCREW-6.5MM X 25MM, STERILE EO
30mm screws were labeled as 25mm screws.
Read the official notice →- Date
- 2023-08-23
- Country
- United States
- Brand
- Conformis
- Product
- CONFORMIS HIP-SCREW-6.5MM X 25MM, STERILE EO
- Classification
- Class II
- Units
- US Nationwide distribution in the states of CA, FL, GA, KS, MA, NV, NY, 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Conformis recalls
- 2025-04-23
USConformis Inc. recalls restor3d Cordera Hip System. ACETABULAR LINER GRP C 36MM LIP. Model Number: HDL-060-C22L-000101 Acetabular Liner for Cordera Hip System
The hip cup liner that was packaged with the incorrect labeling. HDL-060-C22S-000101 from Lot 1788258 contained a hooded liner, but it was labeled to have a standard liner.
FDA · DeviceConformis Inc.US Nationwide distribution in the states of CA, FL, NV, TN.Official notice →- 2024-04-24
- US
Conformis, Inc. recalls Identity Imprint PS Tibial Tray Size 4: Lot 540287
Size 5 Tibial Tray from Lot 508287 was packaged in a Size 4 box from Lot 540287. It was confirmed that Lot 540287 and Lot 508287 were swapped between the pouching and final pack.
FDA · DeviceConformis, Inc.US Nationwide distribution in the states of FL, KS and NH.Official notice → - 2023-02-22
- US
Conformis, Inc. recalls iTotal Identity Impactor Handle, Model No. 1080-212/ED-07827 REV AE
Loctite thread locker (epoxy) may not have been applied to the screw that is part of the handle. In the absence of epoxy, the screw may loosen and fall into the patient during a procedure.
FDA · DeviceConformis, Inc.US Nationwide distribution in the states of AL, AZ, CO, FL, GA, KS, KY, LA,…Official notice → - 2022-04-20
- US
Conformis, Inc. recalls iTotal Identity Posterior Stabilised (PS) Knee Replacement System Model Number: TPS-301-1113-020101
Incorrect tibial base plate implant packaged in kit
Other drugs & medical recalls in the United States
- 2023-08-23
- US
Olympus Corporation of the Americas recalls HF Resection Electrodes - HF resection electrodes are part of a resectoscope system for endoscopic diagnosis and treatment…
Additional Caution statements in IFU: (1) Due to complaints where the loop wire at the distal end of the HF resection electrode broke after getting in contact with metal objects, such as other endoscopic equipment,…
- US
Medtronic Neurosurgery recalls Medtronic REF 46915 Duet External Drainage and Monitoring system, Interlink Injection sites, Ventricular Catheter, STERILE EO, Rx Only
Product labeling contains incorrect expiration date
FDA · DeviceMedtronic NeurosurgeryUS Nationwide distribution in the states of NJ, FL, CA, IL.Official notice → - US
Alcon Research, LTD. recalls Centurion FMS Pak
Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench.
FDA · DeviceAlcon Research, LTD.Worldwide distribution - US Nationwide and the countries of Aland Islands,…Official notice → - US
Olympus Corporation of the Americas recalls UroPass Ureteral Access Sheaths, 5 pieces/box
Dilator tips may break in the package and in patients during surgical procedures.
FDA · DeviceOlympus Corporation of the AmericasWorldwide distribution - United States Nationwide and the countries of South…Official notice → - US
Covidien LP recalls MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 8888102004HP
Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, partially or fully,…
FDA · DeviceCovidien LPUS Nationwide - Worldwide Distribution Foreign: Argentina Austria Bahrain…Official notice → - US
ALEMBIC PHARMACEUTICALS, INC. recalls Tobramycin Opthalmic Solution USP, 0.3%, 5mL bottle, Rx only, Manufactured for: Alembic Pharmaceuticals, Bedminster, NJ 07921,…
Failed Impurities/Degradation Specifications