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

FDA device recall Z-0104-2012 · posted 2011-10-21 · Terminated

Recall details

Recalling firm

Synthes USA (HQ), Inc.

Reason for recall

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.

Action taken

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.

Root cause

Labeling False and Misleading

Status

Terminated

Product code

ODP

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,

Date initiated

2011-09-23

Date posted

2011-10-21

Date terminated

2014-12-18

Location

West Chester, PA

Related 510(k) clearances