The Recall Desk
HighFDA (Devices)·Z-2606-2021·Announced 2021-10-06

Corin Trinity Liner hip implant components recalled due to packaging damage

Corin Ltd is recalling specific Trinity Liner ECIMA hip implant components because packaging damage could compromise device sterility or cause contamination. Five units were distributed nationwide between July 22-26, 2021.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II medical device recall with no reported illnesses, injuries, or deaths. However, the recall addresses a risk-of-harm scenario involving potential loss of sterility in a hip implant component, which poses a serious patient safety concern even though no actual harm has been reported to date.

Plain-English summary

Corin Ltd is recalling two models of Trinity Liner ECIMA hip implant components: the 40mm Neutral Offset Taper Size 4 (REF 322.04.640) and the 36mm Neutral 4mm EPW Taper Size 4 (REF 322.04.936). These liners are components of the Trinity Acetabular System, which is used in hip replacement surgery. A total of 5 units were affected.

The recall was initiated because the packaging system on these devices has potential for physical and water damage. This damage can result in loss of sterility or contamination of the devices. Sterile packaging is critical for surgical implants to prevent infection after implantation.

The affected products were distributed nationwide in Arizona, California, Florida, Illinois, Oklahoma, Pennsylvania, Texas, Utah, and Wisconsin. The specific affected lots were: Model 322.04.640 Lot 479381 (delivered July 22-23, 2021) and Model 322.04.936 Lot 479878 (delivered July 22 and 26, 2021).

Patients who have received or may have received these implants should consult with their physician. Healthcare facilities should check their inventory for the affected lot numbers and contact Corin Ltd or the FDA if they have any of the recalled products.

The recalled product

Product
Corin Trinity Liner ECIMA, diameter 40mm Neutral Offset, Taper Size 4, REF 322.04.640, Sterile; and Corin Trinity Liner ECIMA, diameter 36mm Neutral 4mm EPW, Taper Size 4 (Elevated Wall), REF 322.04.936, Sterile; both are components of the Trinity Acetabular System.
Manufacturer
Corin Ltd
Category
Medical Device — Hip Implant Components
Hazard
  • sterility-loss
  • contamination
  • water-damage
  • packaging-damage

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Model 322.04.936 - Lot number 479878 was delivered 7/22/2021 and 7/26/2021.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category