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Terminated

FlipCutter III Drill

FDA Recall Z-1542-2020 · Posted None

Recalling FirmT.A.G. MEDICAL PRODUCTS CORPORATION, LTD.
Recall StatusTerminated
Product CodeHTO
Date Initiated2020-01-20
Date Terminated2025-04-21
Product Quantity6625 units

Reason for Recall

There is potential for the blister tray to be cracked causing the sterile barrier to be compromised and potential for particulate within the sterile barrier.

Firm Action

Consignees are instructed to return the affected devices which will be replaced.

Root Cause

Packaging process control

Distribution Pattern

Product distributed throughout the United States, Austria, Australia, Bermuda, Switzerland, China, Germany, Denmark, France, Great Britain, Italy, Netherlands, Poland, Sweden and Taiwan.

Official Source

View FDA Recall →

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

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