FDA Medical Device Recalls (openFDA)
Synthes Spine: TI N-Hance Rod 150 mm Sterile, Catalog number 04.600.715.02S spinal fusion surgery
- Recall number
- Z-0966-2009
- Recalling firm
- Synthes Spine
- Product
- TI N-Hance Rod 150 mm Sterile, Catalog number 04.600.715.02S spinal fusion surgery
- Status
- Terminated
- Initiated
- 2008-11-07
- Posted
- 2009-02-03
- Terminated
- 2009-10-05
- Reason
- the dimensional specifications are incorrect
- Root cause
- Nonconforming Material/Component
- Action
- The recalling firm issued an e-mail on 11/18/08 to their sales force to inform them of the problem and the need to remove the product.The recalling firm issued Medical Device recall letters dated 11/19/08 to their customers to inform them of the problem and the need to return the product. Contact Synthes at 800-620-7025 ext. 7025 or 610-719-5750 for additional information.
- Quantity
- 1508 (total)
- Distribution
- Worldwide: AK, AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NH, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV. OUS: Germany, Denmark, Switzerland, and Korea.
- Lot, serial or model codes
- Lot number: 5764185 exp 5/20/2013
- 510(k) numbers
- ["K072685"]
- PMA numbers
- not on file
- Product code
- NQP
- Firm FEI
- 3005180112
- Firm city
- West Chester
- Firm state
- PA
- 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