FDA Medical Device Recalls (openFDA)
Corin Ltd: Corin Trinity-i, diameter 50mm Taper Size 3, Non-Occluded Ti Plasma Shell, REF 320.03.350, Sterile, a component of the Trinity Acetabular System.
- Recall number
- Z-2605-2021
- Recalling firm
- Corin Ltd
- Product
- Corin Trinity-i, diameter 50mm Taper Size 3, Non-Occluded Ti Plasma Shell, REF 320.03.350, Sterile, a component of the Trinity Acetabular System.
- Status
- Terminated
- Initiated
- 2021-07-28
- Posted
- not on file
- Terminated
- 2024-06-12
- Reason
- 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.
- Root cause
- Storage
- Action
- On 7/28&29/2021, the firm sent emails entitled "IMPORTANT-containment request FA COUK 2021 013" which notified the consignee they have been identified as receiving one or more of the medical devices listed in the attached Excel file due to them potentially having physical and/or water damage. They were to quarantine the parts until further instructions were issued. On 9/7/2021, Corin USA issued recall letters dated 9/3/2021 via email on 9/7/2021 requesting the devices be quarantined and returned.
- Quantity
- 2 units
- Distribution
- US Nationwide distribution in the states of AZ, CA, FL, IL, OK, PA, TX, UT, and WI.
- Lot, serial or model codes
- The affected products are shipment specific and were delivered to the consignee between 7/22-26/2021. Lot number 441120 was delivered to the consignee 7/23/2021 and 7/26/2021.
- 510(k) numbers
- ["K123705"]
- PMA numbers
- not on file
- Product code
- MEH
- Firm FEI
- 3002806725
- Firm city
- Cirencester
- Firm state
- not on file
- Firm country
- United Kingdom
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28