FDA Medical Device Recalls (openFDA)
Medtronic Sofamor Danek USA Inc: ATLANTIS(R) Anterior Cervical Plate System Screw Caddy; Self Tapping Variable Screw Caddy (176-513). Medtronic Sofamor Danek USA, Inc. This instrument is a precision device which incorporates a measuring function.
- Recall number
- Z-2984-2011
- Recalling firm
- Medtronic Sofamor Danek USA Inc
- Product
- ATLANTIS(R) Anterior Cervical Plate System Screw Caddy; Self Tapping Variable Screw Caddy (176-513). Medtronic Sofamor Danek USA, Inc. This instrument is a precision device which incorporates a measuring function.
- Status
- Terminated
- Initiated
- 2011-07-06
- Posted
- 2011-08-10
- Terminated
- 2013-04-26
- Reason
- Lines on the screw gauge may not placed on the caddy properly which could result in improper measurement of screws.
- Root cause
- Process control
- Action
- Medtronic Sofamor Danek USA, Inc. sent "Voluntary Recall - Medtronic" letters on July, 2011 to all affected customers. The letter included; description of product and problem, and asked customers to stop using the product. Customers are asked to contact their Sales Representatives for replacement. For question on this recall call Medtronics Global Quality Department at (800) 876-3133.
- Quantity
- 873 units
- Distribution
- Worldwide Distribution: Nationwide distribution including the states of MN, OK, IL, AK, CA, PA, UT, LA, SC, NY, MI, GA, WI, KY, AL, MO, AZ, TN, TX, MA, NE, OH, FL, CO, MT, CT, VA, NC, NH, WA, WV, WY, IN, IA, KS, MT, ME, DE, DC, NJ, MD, MS, NV, HI, ID, ND, and AR; and the country of Uruguay.
- Lot, serial or model codes
- **All lots.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- XLH
- 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