Corin Ltd: Medical Device Recall in 2021 - (Recall #: Z-1291-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Corin BIOLOX DELTA MOD HEAD 36mm EX LONG +8mm12/14 TAPER. Corin Trinity Acetabular System with Extra Long Heads/Trinity Biolox Delta Ceramic Head (Generic Name: Hip Prosthesis). The Trinity Acetabular System is a modular acetabular cup system consisting of a press fit, titanium alloy shell; acetabular liners in neutral offset, +4mm offset, +4mm oblique, neutral 4mm EPW; and ceramic and CoCrMo modular heads. The ceramic and CoCrMo modular heads are compatible with Corin titanium femoral stems. The Trinity Biolox Ceramic heads are packaged in a double peel pouch configuration.

Product Classification:

Class II

Date Initiated: January 25, 2021

Date Posted: March 31, 2021

Recall Number: Z-1291-2021

Event ID: 87293

Reason for Recall:

The size indicated on the labeling on the outer packaging, on the inner packaging, and on the patient stickers inside the packaging is incorrect: the Trinity Biolox Delta Ceramix Head 32XL is labeled as 36XL and vice-versa.

Status: Terminated

Product Quantity: 23 units

Code Information:

Model:104.3615/Lot number:464665

Distribution Pattern:

Worldwide distribution - US Nationwide distribution and the countries of Colombia, Poland, Germany, Australia.

Voluntary or Mandated:

Voluntary: Firm initiated