Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1291-2021 — 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; acetab

U.S. FDA — Device Enforcement · United Kingdom · 2021-01-25 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1291-2021
Date of alert: 2021-01-25
Country / jurisdiction: United Kingdom
Risk level: Class II
Risk type: recall
Brand: Corin Ltd
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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