Recalls / —
—#160709
Product
Medtronic ANGLED DRILL, REF 6630902, QTY: 1 EA Rx only
- FDA product code
- MDM — Instrument, Manual, Surgical, General Use
- Device class
- Class 1
- Medical specialty
- General, Plastic Surgery
- Affected lot / code info
- UDI: 00643169363502, Lot Number EM17F015
Why it was recalled
Medtronic 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 cause (FDA determination)
Process control
Action the firm took
The firm initiated the recall by letter on 12/22/2017, requesting the return of the product.
Recalling firm
- Firm
- Medtronic Sofamor Danek USA Inc
- Address
- 1800 Pyramid Pl, Memphis, Tennessee 38132-1703
Distribution
- Distribution pattern
- MN, NC
Timeline
- Recall initiated
- 2017-12-22
- Terminated
- 2018-07-31
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #160709. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.