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.
Read the official notice →- Date
- 2021-10-06
- Country
- United States
- Brand
- Corin
- Product
- Corin Unity Knee CS Insert, Size 5 / 9.0mm, Fixed Condylar Stabilised - UHMWPE, REF 1125182, Sterile, and Corin Unity Knee CS Insert, Size…
- Classification
- Class II
- Units
- US Nationwide distribution in the states of AZ, CA, FL, IL, OK, PA, TX, UT,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2023-11-08
USCorin 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.
- 2022-12-28
- US
Corin 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.
Other drugs & medical recalls in the United States
- 2021-10-06
- US
Angiodynamics Inc. (Navilyst Medical Inc.) recalls Xcela PICC with PASV Valve Technology/Kit 5 F-55cm; (Maximum Flow Rate 3.5 mL/Sec)-indicated for short or long-term…
Mislabeled: The product is labeled as 5F (55cm; Maximum Flow Rate 3.5 mL/Sec) and the product is actually 4F (55cm; Maximum Flow Rate 3.5 mL/Sec).
- US
Datascope Corp. recalls Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34,…
The Cardiosave IABP may unexpectedly shut down when the device is running on AC power, only one battery is installed in the IABP, and the battery is physically removed while the battery is being charged. This occurs…
FDA · DeviceDatascope Corp.Nationwide domestic distribution. Foreign distribution worldwide.Official notice → - US
ConvaTec, Inc recalls DuoDERM Control Gel Formula Border Dressings 15x15cm (1x5pk)
Primary packaging labeling may be incorrect.
FDA · DeviceConvaTec, IncDistribution in US and Canada US distribution in CA, FL, GA, IL, MD, MN, NC.…Official notice → - US
Beckman Coulter Inc. recalls DxA 5000 (DxA Automation System, DxA 5000 fit), "For in Vitro Diagnostic Use", Reference Numbers: B87352 with B57634, UDI: 15099590707118
There is a potential that sample carriers (w or w/o samples) within automated sampling system may transport samples to the outer lane which does not contain a physical barrier to restrain samples. Samples are dropped…
FDA · DeviceBeckman Coulter Inc.US Nationwide distribution in the states of AL, CA, IL, In, KY, MN, MI, OH,…Official notice → - US
Hill-Rom, Inc. recalls LikoStretch Mod 600 IC Model Number: 3156065 LikoStretch Mod 600 IC, Wide Model Number: 3156065B (obsolete since 12JUN2020) - The…
Stretch Leveller has the potential to lose the function of maintaining a patient in the horizontal position when lifting and in motion. When this function is lost the patient can slide backwards and potentially may…
FDA · DeviceHill-Rom, Inc.Worldwide distribution - US Nationwide distribution in the states of AZ, CA,…Official notice → - US
GE Healthcare, LLC recalls Flow sensors that may be installed in the following GEHC anesthesia machines: (1) Aestiva MRI, GTIN 0080682102339; (2) Aestiva 7900; (3)…
The flow sensors built prior to June 2021 could have damaged tubes with small punctures or cuts that could cause leaks resulting in incorrect anesthesia machine tidal volumes potentially leading to over-delivery of…
FDA · DeviceGE Healthcare, LLCDistribution was nationwide, including PR. Foreign distribution was made to…Official notice →