Device 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. The Trinity Biolox Ceramic heads are packaged in a double peel pouch configuration.
Z-1290-2021
Product summary
- Firm
- Corin Ltd
- Event
- Event 87293
- Status
- Terminated
- Classification
- Class II
- Quantity
- 23 units
- Official record key
device-enforcement:Z-1290-2021
Official wording
Reason: 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.
Code information: Model:104.3215/Lot number:464664
Distribution pattern: Worldwide distribution - US Nationwide distribution and the countries of Colombia, Poland, Germany, Australia.
Derived failure modes
-
Unknown
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.