Corin BIOLOX Delta Mod Head recall: Sterility Concern
Corin BIOLOX Delta Mod Head, diameter 28mm Medium 0mm, 12/14 Taper, REF 104.2805, Sterile, a component of the Trinity Acetabular System.
Why was Corin BIOLOX Delta Mod Head recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
The affected products are shipment specific and were delivered to the consignee between 7/22-26/2021. Lot number 483603 was delivered 7/23/2021.
- Product
- Corin BIOLOX Delta Mod Head, diameter 28mm Medium 0mm, 12/14 Taper, REF 104.2805, Sterile, a component of the Trinity Acetabular System.
- Recalling firm
- Corin Ltd
- Quantity
- 4
- Distribution
- US Nationwide distribution in the states of AZ, CA, FL, IL, OK, PA, TX, UT, and WI.
- Recall date
- October 6, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)