FDA Medical Device Recalls (openFDA)
Medtronic Sofamor Danek USA Inc: Medtronic ANGLED DRILL, REF 6630902, QTY: 1 EA Rx only
- Recall number
- Z-0566-2018
- Recalling firm
- Medtronic Sofamor Danek USA Inc
- Product
- Medtronic ANGLED DRILL, REF 6630902, QTY: 1 EA Rx only
- Status
- Terminated
- Initiated
- 2017-12-22
- Posted
- not on file
- Terminated
- 2018-07-31
- Reason
- 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
- Process control
- Action
- The firm initiated the recall by letter on 12/22/2017, requesting the return of the product.
- Quantity
- 2 units
- Distribution
- MN, NC
- Lot, serial or model codes
- UDI: 00643169363502, Lot Number EM17F015
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MDM
- Firm FEI
- 1000477302
- Firm city
- Memphis
- Firm state
- TN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28