Corin Ltd recalls Unity Total Knee System, Model Number 112.001.34. Primary and revision total knee arthroplasty
Potential for Unity CR Inserts Right size 6 from batch 529803 to be incorrectly labelled as Unity CR Inserts Right size 7 from batch 532405 and visa versa.
Read the official notice →- Date
- 2023-11-08
- Country
- United States
- Brand
- Corin
- Product
- Unity Total Knee System, Model Number 112.001.34. Primary and revision total knee arthroplasty
- Classification
- Class II
- Units
- US: MI, TX, IL
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Corin recalls
- 2022-12-28
USCorin Ltd recalls Corin BIOLOX DELTA MOD HEAD, 036mm EX LONG +8mm, REF 104.3615
The BIOLOX Delta Ceramic Head size 36XL is labelled as the size 32XL and vice-versa.
FDA · DeviceCorin LtdUS Nationwide distribution in the states of FL, GA, MA, MI, Ok, PA, TX.Official notice →- 2022-11-30
- US
Corin Ltd recalls Unity Total Knee System. Used for knee prosthesis in total knee replacement
The internal packaging system for devices may have damage to the blisters potentially damaging the device or compromising the sterility of the packaging.
FDA · DeviceCorin LtdDistribution in the US to New Jersy and Puerto Rico. International…Official notice → - 2022-09-07
- US
Corin Ltd recalls TaperFit Stem, Size 0, 38mm OFFSET, 12/14 Taper + 188.550 Centraliser, For Cemented Use, REF 588.3800. Orthopedic hip implant component.
Some of the devices did not pass fatigue testing.
FDA · DeviceCorin LtdDistribution was made to NJ. There was no military/government distribution.Official notice → - 2022-08-17
- US
Corin Ltd recalls Corin METAFIX HIP STEM, SIZE 3, STANDARD, 135 degrees, COLLARED HIP STEM, CEMENTLESS, Part Number 579.0103
One MetaFix size 7 collarless stem from batch 478179 which was incorrectly labelled as a MetaFix size 3 collared stem from batch 485630.
- 2021-10-06
- US
Corin Ltd recalls Corin Unity Knee CS Insert, Size 5 / 9.0mm, Fixed Condylar Stabilised - UHMWPE, REF 1125182, Sterile, and Corin Unity Knee CS Insert, Size…
The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices.
FDA · DeviceCorin LtdUS Nationwide distribution in the states of AZ, CA, FL, IL, OK, PA, TX, UT,…Official notice →
Other drugs & medical recalls in the United States
- 2023-11-15
- US
Dr. Reddy's Laboratories, Inc. recalls Montelukast Sodium Tablets, USP 10 mg, Rx Only, 1000 count bottle, Distributed by: Dr. Reddy's Laboratories., Princeton, NJ…
Presence of Foreign Tablet(s)/Capsule(s): A foreign tablet was found in a bottle of Montelukast Sodium Tablets, USP 10mg, identified as metoprolol 25 mg.
- 2023-11-08
- US
Medtronic Neuromodulation recalls LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device.
There are a small number of units of the DBS Lead with StimLoc kit (3387S-40) due to a discrepancy in the Use By Date (UBD) printed on the outer packaged kit label versus the UBD printed on the individual product label.
- US
Cepheid recalls Xpert Xpress Strep A, REF:Xprstrepa-CE-10, CE IVD,
pipettes packaged in Strep A test may fail to dispense an adequate sample volume which could result in "invalid" results or no result test results.
FDA · DeviceCepheidWorldwide distribution - US Nationwide and the countries of Costa Rica,…Official notice → - US
Baxter Healthcare Corporation recalls HILLROM PROGRESSA+ BED, Product Codes: P7501A000016, P7501A000019, P7501A000031, P7501A000032, P7501A000033, P7501A000052,…
Progressa+ beds have the potential for static buildup from the casters and/or power drive. This static electricity could be passed to the operator through the transport handle during transport, resulting in a mild…
FDA · DeviceBaxter Healthcare CorporationUS Nationwide Distribution in the states of: CA, FL, IN, MA, NY, OH, TX, VAOfficial notice → - US
Cosmedent, Inc. recalls Cosmedent FlexiCup Composite Finishing & Polishing System, Six Pack, Autoclavable Aluminum Oxide Polishing Instrument, Medium (Blue), REF…
Reports were received the elastomer cup material is crumbling.
FDA · DeviceCosmedent, Inc.Worldwide distribution - US Nationwide and the countries of Australia,…Official notice → - US
Maquet Cardiovascular, LLC recalls Vasoview 6 Pro (VV6) - Endoscopic Vessel Harvesting System, Model VH-2400 printed on outer label, inner label and IFU, outer box…
Device packaged inside an incorrect outer box; displaying artwork & illustrations for a different device.
FDA · DeviceMaquet Cardiovascular, LLCUS (AL, AR, CA, FL, GA, IN, KY, MI, NJ, OK, PA, TN, TX) and Canada.Official notice →