FDA Medical Device Recalls (openFDA)
X Spine Systems Inc: Xpress System Pedicle Screw Assembly, 5.5 x 55mm. An internal fixation device for spinal surgery consisting of rods, pedicle screw assemblies (screw, cap, yoke) and cross bar connector assemblies.
- Recall number
- Z-1512-2015
- Recalling firm
- X Spine Systems Inc
- Product
- Xpress System Pedicle Screw Assembly, 5.5 x 55mm. An internal fixation device for spinal surgery consisting of rods, pedicle screw assemblies (screw, cap, yoke) and cross bar connector assemblies.
- Status
- Terminated
- Initiated
- 2015-03-11
- Posted
- 2015-04-22
- Terminated
- 2015-10-21
- Reason
- One lot of instruments have etched on the Yoke of the Pedicle Screw a laser marking size of 7.5 x 55mm instead of 5.5 x 55mm as described on the product label.
- Root cause
- Nonconforming Material/Component
- Action
- The firm, X-spine Systems, Inc., sent an "Urgent Medical Device Recall" letter dated March 19, 2015 to their customers. The letter describes the product, problem and actions to be taken. The customers were instructed to notify affected hospital and surgeon of the recall immediately; complete the attached Medical Device Recall Return Response Form and return it with any affected product in inventory to X-Spine Systems immediately via mail: 725 Alexandersville Road, Miamisburg OH 45342-RMA #5288; and No action should be taken with product that has been implanted. Please contact customer service at 800.903.0640 or email orders@x-spine.com with any questions.
- Quantity
- 14 units
- Distribution
- US Distribution to states of: KS, NV & TX.
- Lot, serial or model codes
- Lot #: 4084-01; M/N X073-5555; UDI: *+M697X07355551/$408401U*
- 510(k) numbers
- ["K120832"]
- PMA numbers
- not on file
- Product code
- MNH
- Firm FEI
- 3005031160
- Firm city
- Miamisburg
- Firm state
- OH
- 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
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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