—#122363

Product

Synthes Titanium Cannulated Humeral Nail Intended to aid in the alignment and stabilization of humeral fractures

FDA product code: JDS — Nail, Fixation, Bone
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K033071
Affected lot / code info: Part # Lot # 04.001.620S 7115414 04.001.620S 7115417 04.001.620S 7115509 04.001.620S 7115510 04.001.622S 7115533 04.001.636S 7117902 04.001.636S 7117916 04.001.638S 7117924 04.001.640S 7119089 04.001.640S 7119107 04.001.642S 7117995 04.001.642S 7119125 04.001.644S 7117998 04.001.218S 7327816 04.001.444S 7379241 04.001.620s 7265517

Why it was recalled

The packaging incorrectly depicts the Synthes Titanium Cannulated Humeral Nail as a 3 distal hole nail instead of a 2 distal locking hole nail.

Root cause (FDA determination)

Pending

Action the firm took

Synthes sent an Urgent Notice: Medical Device Recall letter dated July 30, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to call Synthes at 1-800-479-6329 to obtain a Return Authorization Number, complete the Verification Section and return to Credit/Returns, Synthes, 1101 Synthes Avenue, Monument, CO 80132. If customers do not have any affected product they should still complete Verification Form and return to Synthes by fax to 1-888-731-7954 or Scan/email: FieldAction@synthes.com. Customers with questions were instructed to call 610-719-5450. For questions regarding this recall call 610-519-5000.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution - USA (nationwide) including SC, IA, NC, TX, KY, VA, AL, PA, and Internationally to Canada.

Timeline

Recall initiated: 2013-07-30
Posted by FDA: 2013-11-27
Terminated: 2015-09-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #122363. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.