FDA Medical Device Recalls (openFDA)
Alphatec Spine, Inc.: Alphatec Spine Solanas Titanium Pedicle Screw, Part Number 63035-12
- Recall number
- Z-0502-2010
- Recalling firm
- Alphatec Spine, Inc.
- Product
- Alphatec Spine Solanas Titanium Pedicle Screw, Part Number 63035-12
- Status
- Terminated
- Initiated
- 2009-08-05
- Posted
- 2009-12-14
- Terminated
- 2010-06-07
- Reason
- Alphatec Spine discovered that the affected lots were not manufactured correctly in that the screw body portion of the assembly has only 22.5 degrees of angulation in the east-west plane instead of the designed 38-40 degrees.
- Root cause
- Process control
- Action
- Alphatec Spine telephoned consignees informing them of the above mentioned Public Reason for Recall on August 5, 2009. They were asked to check their inventory to see where this product is located. If the product had not already been used Alphatec arranged to have Federal Express contact consignee for pick-up of the product(s). They were told to expect to receive the replacement(s) within 2-3 days.
- Quantity
- 163 Units
- Distribution
- Nationwide distribution.
- Lot, serial or model codes
- Lot Numbers: 624239, 624240
- 510(k) numbers
- ["K052201","K071380"]
- PMA numbers
- not on file
- Product code
- KWP
- Firm FEI
- 2027467
- Firm city
- Carlsbad
- Firm state
- CA
- 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