NFlex Stabilization System 150mm The Synthes N-Hance and NFix II rods are intended to provide immobilization and stabili

FDA device recall Z-2348-2010 · posted 2010-09-01 · Terminated

Recall details

Recalling firm

Synthes USA (HQ), Inc.

Reason for recall

package integrity compromised

Action taken

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.

Root cause

Equipment maintenance

Status

Terminated

Product code

NQP

Distribution

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 coun

Date initiated

2009-02-09

Date posted

2010-09-01

Date terminated

2010-09-15

Location

West Chester, PA

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