FDA Medical Device Recalls (openFDA)
Spine Smith Partners LP: Cynch Lordotic T-PLlF Implant. Intervertebral fusion device with bone graft, for use with supplemental fixation.
- Recall number
- Z-0932-2013
- Recalling firm
- Spine Smith Partners LP
- Product
- Cynch Lordotic T-PLlF Implant. Intervertebral fusion device with bone graft, for use with supplemental fixation.
- Status
- Terminated
- Initiated
- 2012-08-24
- Posted
- 2013-03-10
- Terminated
- 2013-05-17
- Reason
- Implants were incorrectly laser marked as 23mm instead of 28mm.
- Root cause
- Labeling mix-ups
- Action
- Spine Smith sent a Field Action Notice dated August 24, 2012 to its affected customer. The letter identified the product, problem, and actions to be taken by the customer. Contact the firm at 512-637-2097 for questions concerning this notice.
- Quantity
- 3 units
- Distribution
- Distributed in Texas.
- Lot, serial or model codes
- Part Number: 0609-2809-06, Lot: 39AQ
- 510(k) numbers
- K101085
- PMA numbers
- not on file
- Product code
- MAX
- Firm FEI
- 3010266937
- Firm city
- Austin
- Firm state
- TX
- 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