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.
This recall has been terminated (originally issued January 25, 2021).
- Recall Initiated
- January 25, 2021
- Terminated
- November 23, 2022
- Recall Number
- Z-1290-2021
- Quantity
- 23 units
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Worldwide distribution - US Nationwide distribution and the countries of Colombia, Poland, Germany, Australia.
Lot / Code Info
Model:104.3215/Lot number:464664
Root Cause
Labeling mix-ups
Action Taken
The firm contacted their consignee by email on 01/25/2021. The distributor was instructed to identify the affected product in its inventory and return it to Corin USA in order to contain the part. A recall letter will be sent and acknowledgement of receipt will be requested.