Corin Ltd: 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.

Agency Publication Date: March 22, 2021

Affected Products

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

Model:104.3215/Lot number:464664

Lot Numbers:

number

Product: 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.

Model:104.3615/Lot number:464665

Lot Numbers:

number

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 87293

Status: Resolved

Manufacturer: Corin Ltd

Manufactured In: United Kingdom

Units Affected: 2 products (23 units)

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Sources: FDA iRES · Raw API Response

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Affected Products

Model:104.3215/Lot number:464664

Lot Numbers:

number

Model:104.3615/Lot number:464665

Lot Numbers:

number