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Open, Classified

Corin BIOLOX DELTA MOD HEAD,032mm, EX LONG +7mm, REF 104.3215

FDA Recall Z-0726-2023 · Posted 2022-12-19

Recalling FirmCorin Ltd
Recall StatusOpen, Classified
Product CodeLZO
Date Initiated2022-11-08
Product Quantity5 units

Reason for Recall

The BIOLOX Delta Ceramic Head size 36XL is labelled as the size 32XL and vice-versa.

Firm Action

The firm issued a FIELD SAFETY NOTICE/RECALL LETTER on 11/08/2022 by email. The notice explained the issue, potential risk to health, and post implantation recommendations. The following actions were requested: - Return the device from the filed to Coring USA Limited, Paramount Drive, Raynham, MA 02767, USA - Complete the acknowledgment of receipt and forward to [email protected] to confirm receipt of the Field Safety Notice/Recall Letter. For further information concerning this event, contact: [email protected]

Root Cause

Under Investigation by firm

Distribution Pattern

US Nationwide distribution in the states of FL, GA, MA, MI, Ok, PA, TX.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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