FDA Medical Device Recalls (openFDA)
Sulzer Spine-Tech: Spine-Tech Ancillary Discectomy Instrument (Box Curette), Catalog Number 07.00254.001, in Spine-Tech Ancillary Discectomy Instrument Set, Catalog Number 07.00316.001.
- Recall number
- Z-0559-03
- Recalling firm
- Sulzer Spine-Tech
- Product
- Spine-Tech Ancillary Discectomy Instrument (Box Curette), Catalog Number 07.00254.001, in Spine-Tech Ancillary Discectomy Instrument Set, Catalog Number 07.00316.001.
- Status
- Terminated
- Initiated
- 2003-01-17
- Posted
- 2003-02-21
- Terminated
- 2003-05-28
- Reason
- With 14 units distributed, there have been 10 complaints of the product having a twisted or broken tip.
- Root cause
- Other
- Action
- The firm sent a letter, dated January 17, 2003, which requested that the consignees return the product.
- Quantity
- 14 instruments
- Distribution
- The instruments to be recalled are at 2 consignees in California and Mississippi. 21 units are with the firm''s sales representatives.
- Lot, serial or model codes
- Lot numbers P010900 and P010957
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LXH
- Firm FEI
- 1000115775
- Firm city
- Minneapolis
- Firm state
- MN
- 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