medical Class II Updated 2021-03-31

Corin Ltd recalls Corin BIOLOX DELTA MOD HEAD 36mm EX LONG +8mm12/14 TAPER. Co

Recalled 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. The Trinity Biolox Ceramic heads are packaged in a double peel pouch configuration.


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Model:104.3615/Lot number:464665
View official government recall

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