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Corin Ltd Recall 87293

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.

Corin Ltd Recall 87293 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1290-2021
Event ID87293
Event DescriptionCorin 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.
Product TypeDevices
DistributionWorldwide distribution - US Nationwide distribution and the countries of Colombia, Poland, Germany, Australia.
Quantity23 units
Recall ReasonThe 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.
Device Classification20210331
Device Code InfoModel:104.3215/Lot number:464664
Center Classification Date20210322
Recall Initiation Date20210125
Recalling FirmCorin Ltd
Initial Notification E-Mail
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