BRASSELER KM166-310-35 Twist Drill Quick Connect Diameter 3.5 mm, Total Length 112mm, Effective Length, 86mm - Product Usage: Twist drill intended use: to drill into bone in hip or knee surgeries.
FDA Recall Z-0591-2020 · Posted None
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Recalling FirmBrasseler USA I Lp
Recall StatusTerminated
Product CodeGFF
Date Initiated2019-10-18
Date Terminated2020-12-14
Product Quantity387 units
Reason for Recall
One lot of 3.5 mm twist drills were incorrectly laser etched as 2.5 mm the shaft of the device.
Firm Action
Initial contact to customers was by telephone and visit on 18 October 2019. The firm followed with a letter disseminated by email on 10/25/2019. The firm is seeking return of the affected units and will replace them with correct devices.
Root Cause
Under Investigation by firm
Distribution Pattern
US Nationwide distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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