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Terminated

Evans Wedge Disposable Trials, Large Footprint, 8mm Thickness (Model: 6101-22200818). Orthopedic manual surgical instrument

FDA Recall Z-1028-2022 · Posted 2022-04-29

Recalling Firmrestor3d Inc.
Recall StatusTerminated
Product CodeLXH
Date Initiated2022-03-30
Date Terminated2023-08-28
Product Quantity9 units

Reason for Recall

During re-work of disposable instruments to relabel for 4-year shelf-life of disposable instruments, parts got mixed into other lots.

Firm Action

An email was sent out to the consignees on 03/31/2022. All customers were instructed to segregate any affected product and contact Restor3d. If all product has already been returned to restor3d, the consignee is to indicate that on the enclosed response form. On 04/19/2022, the firm extended the recall to two additional lots. The recall notification was sent to the consignees via email with a request for all affected product to be returned.

Root Cause

Process change control

Distribution Pattern

US Nationwide distribution in the states of KY, NC, NJ, TX, IN, VA and AL.

Official Source

View FDA Recall →

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

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