Recall Z-1290-2021— Corin Ltd

Name: FDA recall Z-1290-2021
Creator: U.S. Food and Drug Administration
Published: 2021-01-25

Class II · Terminated

Class II FDA medical device recall by Corin Ltd, initiated 2021-01-25, terminated 2022-11-23. It names one FDA 510(k) clearance: K130343. Product: Corin BIOLOX DELTA MOD HEAD 32mm EX LONG +7mm 12/14 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.. Reason: 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..

Recalling firm: Corin Ltd
Classification: Class II
Status: Terminated
Initiated: 2021-01-25
Terminated: 2022-11-23
Firm location: Cirencester, N/A, United Kingdom

510(k) clearances named in this recall

1 on FDA's record

K130343 — CORIN TRINITY ACETABULAR SYSTEM WITH EXTRA-LONG HEADSCorin USA·cleared 2013-05-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Corin BIOLOX DELTA MOD HEAD 32mm EX LONG +7mm 12/14 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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.