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Terminated

TaperFit Stem, Size 0, 38mm OFFSET, 12/14 Taper + 188.550 Centraliser, For Cemented Use, REF 588.3800. Orthopedic hip implant component.

FDA Recall Z-1667-2022 · Posted None

Recalling FirmCorin Ltd
Recall StatusTerminated
Product CodeJDI
Date Initiated2022-07-12
Date Terminated2026-05-04
Product Quantity1

Reason for Recall

Some of the devices did not pass fatigue testing.

Firm Action

The recalling firm issued the recall letter dated 7/8/2022 via email to the consignee on 7/12/2022. The recall letter described the potential issue and listed the affected product. The potential risk was reported and the actions to be carried out by the customer, which included return of the product from the field and completion of the acknowledgement form to be returned via email to confirm receipt of the letter.

Root Cause

Under Investigation by firm

Distribution Pattern

Distribution was made to NJ. There was no military/government distribution.

Official Source

View FDA Recall →

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

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