FDA Medical Device Recalls (openFDA)
Medtronic Sofamor Danek USA Inc: ATLANTIS(R) Anterior Cervical Plate System VARIABLE ANGLE SCREW MODULE, REF 176-503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
- Recall number
- Z-0036-2013
- Recalling firm
- Medtronic Sofamor Danek USA Inc
- Product
- ATLANTIS(R) Anterior Cervical Plate System VARIABLE ANGLE SCREW MODULE, REF 176-503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
- Status
- Terminated
- Initiated
- 2012-08-30
- Posted
- 2012-10-10
- Terminated
- 2013-08-15
- Reason
- Lines on the screw gauge may not placed on the caddy properly which could result in improper measurement of screws. An incorrect gauge could measure a screw to be approximately 1 mm shorter than its actual length.
- Root cause
- Nonconforming Material/Component
- Action
- Medtronic conducted a conference call on August 30, 2012 and sent an "URGENT VOLUNTARY RECALL" notice dated September 3, 2012 to all affected customers. The notice identified the product, problem, and actions to be taken by the customers. A Recall Questionnaire Form was attached to the letter for customers to complete and return. Contact your Medtronic Sales representative or the firm's Global Quality Department at 800-876-3133, ext. 3197 for questions regarding this notice.
- Quantity
- 1047 units
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of India, Netherlands, Hong Kong, S. L Korea, Singapore, Canada, Australia, Japan, and Mexico.
- Lot, serial or model codes
- All lots except those starting with SY
- 510(k) numbers
- ["K021461","K063100","K081038"]
- PMA numbers
- not on file
- Product code
- KWQ
- 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