—#93233

Product

NFlex Straight monosegmental L 150mm The Synthes N-Hance and NFix II rods are intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the spine.

FDA product code: NQP — Posterior Metal/Polymer Spinal System, Fusion
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K061774, K072685
Affected lot / code info: Catalog number 04.600.716.02S. Lot numbers: 5794446 and 5842468

Why it was recalled

package integrity compromised

Root cause (FDA determination)

Equipment maintenance

Action the firm took

The firm, SYNTHES, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated February 9, 2009 and an updated letter dated February 12, 2009, with updated expiration information to customers. The letters described the product, problem and action to be taken by customer. The customers were instructed to call Synthes at 1-800-479-6329 if they have any of the identified devices to obtain a Return Authorization Number; complete the enclosed Verification Section attachment and return this letter with the recalled product to Credit/Returns, Synthes, 1101 Synthes Avenue, Monument, CO 80132. If they do not have the identified product ,complete the Verification Section attachment and return the document to Synthes by Fax 610-719-5120 or scan/email: lewis.lynne@synthes.com. If you have any questions, please call 800-620-7025 x 5454 or 610-719-5454 or contact your Synthes Spine Sales Consultant.

Recalling firm

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

Distribution

Distribution pattern: Worldwide distribution: USA including states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NJ, NM, NV, NY, OH, OR, PA, SC, TN , TX, UT, VA, WA, WI, and WV and countries including Denmark, Germany, Korea and Switzerland.

Timeline

Recall initiated: 2009-02-09
Posted by FDA: 2010-09-01
Terminated: 2010-09-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #93233. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.