FDA Medical Device Recalls (openFDA)
Synthes USA (HQ), Inc.: Synthes Spine Zero-P Instruments and Implants. Zero-profile anterior cervical interbody fusion (ACIF) device.
- Recall number
- Z-0104-2012
- Recalling firm
- Synthes USA (HQ), Inc.
- Product
- Synthes Spine Zero-P Instruments and Implants. Zero-profile anterior cervical interbody fusion (ACIF) device.
- Status
- Terminated
- Initiated
- 2011-09-23
- Posted
- 2011-10-21
- Terminated
- 2014-12-18
- Reason
- LABELING CORRECTION - Following review of labeling and promotional materials associated with the Zero-P Implant system, it was found that the materials reference a study where PEEK-CR is utilized as a cervical interbody spacer. PEEK-CR is not currently indicated for use as a cervical interbody spacer.
- Root cause
- Labeling False and Misleading
- Action
- Synthes (USA) sent an "URGENT: MEDICAL DEVICE LABELING CORRECTION" letter dated September 23, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to review the updated supplemental labeling page included with the letter and replace/attach the technique guide page in any Zero-P technique guide that customers may have. The Verification Section of the letter is to be completed and returned to Synthes via fax at 610-251-9005. For questions regarding this notice call 1-800-620-7025 ext. 5403.
- Quantity
- not on file
- Distribution
- USA (nationwide) including Puerto Rico, Washington, DC and the states of AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and WY.
- Lot, serial or model codes
- N/A - Labeling Correction
- 510(k) numbers
- ["K072981","K093762"]
- PMA numbers
- not on file
- Product code
- ODP
- 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