—#104222

Product

Synthes Spine Zero-P Instruments and Implants. Zero-profile anterior cervical interbody fusion (ACIF) device.

FDA product code: ODP — Intervertebral Fusion Device With Bone Graft, Cervical
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K072981, K093762
Affected lot / code info: N/A - Labeling Correction

Why it was recalled

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 (FDA determination)

Labeling False and Misleading

Action the firm took

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.

Recalling firm

Firm: Synthes USA (HQ), Inc.
Address: 1302 Wrights Ln E, West Chester, Pennsylvania 19380-3417

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2011-09-23
Posted by FDA: 2011-10-21
Terminated: 2014-12-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #104222. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.