FDA Device

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

Hazard

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.

What You Should Do

Remedy

The firm contacted their consignee by email on 01/25/2021. The distributor was instructed to identify the affected product in its inventory and return it to Corin USA in order to contain the part. A recall letter will be sent and acknowledgement of receipt will be requested.

Products

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 Acetab
Brand
Corin Ltd Unit 1-57-8 Corinium Centre Cirencester United Kingdom
UPC
Model:104.3215/Lot number:464664

Units Affected

23 units