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.
Enforcement
- Recall Number
- Z-1291-2021
- Event ID
- 87293
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Corin Ltd
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- March 31, 2021
- Initiation Date
- January 25, 2021
- Classification Date
- March 22, 2021
- Termination Date
- November 23, 2022
- Address
- Unit 1-57-8, Corinium Centre, Cirencester, N/A, N/A, United Kingdom
Description
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.
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.
Model:104.3615/Lot number:464665
Worldwide distribution - US Nationwide distribution and the countries of Colombia, Poland, Germany, Australia.
23 units