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Terminated

SST TWIST DRILL, STANDARD, 1.6mm Dia. x 127mm, REF 8054-010, STERILE This product line is intended for use in orthopaedic surgery (large and small bone surgeries) to cut bone

FDA Recall Z-0412-2018 · Posted None

Recalling FirmMicroAire Surgical Instruments, LLC
Recall StatusTerminated
Product CodeHTW
Date Initiated2017-05-22
Date Terminated2018-08-29
Product Quantity42

Reason for Recall

One lot was found to contain both the correct twist drill (1.6mm) as well as an incorrect twist drill (2.0mm)

Firm Action

MicroAire Surgical Instruments, LLC distributed recall letters on May 22, 2017 MicroAire Surgical Instruments, LLC distributed recall letters to the customers who received the mislabeled twist. Letters will be sent by UPS to expedite the delivery. For further questions, please call (434) 975-8000

Root Cause

Labeling mix-ups

Distribution Pattern

US Distribution.

Official Source

View FDA Recall →

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

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