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Terminated

Non-Sterile Double Ended Trial Kit, Small Footprint, (6110-N01-KTS01) for the Cervical Cage. The kit includes 3 trials. Orthopedic manual surgical instrument

FDA Recall Z-1026-2022 · Posted 2022-04-29

Recalling Firmrestor3d Inc.
Recall StatusTerminated
Product CodeLXH
Date Initiated2022-03-30
Date Terminated2023-08-28
Product Quantity14 units

Reason for Recall

Product labeled incorrectly. The lot was labeled with Small footprint when the product was Medium.

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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