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Terminated

Calcaneus Plate, Extensile, Small, Right, Catalog Number CPF 201 - Product Usage: intended to be used for internal fixation of fractures and reconstruction of bones of the rearfoot, including the calcaneus.

FDA Recall Z-2785-2020 · Posted 2020-08-12

Recalling FirmFlower Orthopedics Corporation
Recall StatusTerminated
Product CodeHRS
Date Initiated2020-07-08
Date Terminated2020-10-08
Product Quantity25

Reason for Recall

The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to manufacture the plates (a titanium alloy rather than pure titanium).

Firm Action

The Regional Business Director notified the customer by telephone and informed them that there was an issue with the newly released calcaneus plates. The 6 units were requested to be returned to Flower Orthopedics.

Root Cause

Mixed-up of materials/components

Distribution Pattern

US Nationwide distribution including in the states of AZ, FL, and OH.

Official Source

View FDA Recall →

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

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