Drill, 2.7x125mm, AO, Item Number 502015217
FDA Recall Z-1433-2019 · Posted None
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Recalling FirmZimmer GmbH
Recall StatusTerminated
Product CodeHTW
Date Initiated2019-04-08
Date Terminated2020-05-11
Reason for Recall
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Firm Action
Urgent Medical Device Recall notification letters dated 4/8/19 were sent to customers.
Root Cause
Under Investigation by firm
Distribution Pattern
The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.
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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