ClearanceBrief
Recall Z-0566-2018 ยท MDM Instrument, Manual, Surgical, General Use

Medtronic Sofamor Danek USA Inc

Medtronic ANGLED DRILL, REF 6630902, QTY: 1 EA Rx only

DateDec 22, 2017
StatusTerminated
ReasonMedtronic has discovered the product lot in question was noted as having a longer drill tip extension than what is indicated on the print specification.
Root causeProcess control
ActionThe firm initiated the recall by letter on 12/22/2017, requesting the return of the product.
Quantity2 units
DistributionMN, NC
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.