The Recall Desk
ModerateFDA (Devices)·Z-1528-2016·Announced 2016-05-04

Corin Trinity Acetabular Shell Recall Due to Packaging Abrasion Risk

Corin USA Limited is recalling 629 Trinity Acetabular Shells used in total hip replacements because the new packaging system may abrade the sterile barrier pouches.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a potential packaging defect (abrasion) that could compromise sterility, but no specific injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Corin USA Limited is recalling 629 units of the Trinity Acetabular Shell, a medical device used for total hip replacement. The recall is due to a potential for abrasion of the sterile barrier pouches associated with the new packaging system.

The affected devices are distributed worldwide, including in the United States (California, Florida, Idaho, Texas, Oklahoma, Ohio, Massachusetts, and North Carolina) and in Australia, Belgium, Egypt, Germany, Ghana, Italy, Japan, Poland, South Africa, and the United Kingdom. The specific lots involved include No Hole Shell 048mm Taper Size 2 (Lot Codes: 322986, 323743, 320026, 322977, 323744) and No Hole Shell 052mm Taper Size 3 (Lot Codes: 322396, 322971, 322403, 322984, 322985, 323750).

Healthcare providers and patients should check their device lot numbers against the list provided by the manufacturer. If a device is affected, it should be removed from use and returned to Corin USA Limited for evaluation or replacement.

The recalled product

Product
Trinity Acetabular Shell Product Usage Total Hip Replacement.
Manufacturer
Corin USA Limited
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
629

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 (13)

  • No Hole Shell 048mm Taper Size 2
  • Lot Codes: 322986
  • 323743
  • 320026
  • 322977
  • 323744
  • No Hole Shell 052mm Taper Size 3
  • Lot Codes: 322396
  • 322971
  • 322403
  • 322984
  • 322985
  • 323750.

Distribution

Distributed nationwide across the United States.

The notice also names 8 states specifically:

Part of a larger recall action

This product is one of 3 recalled by Corin USA Limited under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same manufacturer · Corin USA Limited

See all →

Same hazard · packaging defect

See all →