Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

NFix II System 200 mm, Catalog number NX60200-1. spinal fusion surgery

FDA Recall Z-0964-2009 · Posted 2009-02-03

Recalling FirmSynthes Spine
Recall StatusTerminated
Product CodeNQP
Date Initiated2008-11-07
Date Terminated2009-10-05
Product Quantity1508 (total)

Reason for Recall

the dimensional specifications are incorrect

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K061774NFIX II PEDICLE SCREW SYSTEMN Spine, Inc. · 2006-12-13

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑