—#138343

Product

16mm Chisel Blade; used in the LCP Anterior Ankle Arthodesis Plate System and the Hip Preservation Surgery Set. Orthopedic manual surgical instrument.

FDA product code: FZO — Chisel, Surgical, Manual
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Part Number 399.56 Lot Numbers T106341

Why it was recalled

It was discovered that a 10mm Chisel Blade was etched as a 16mm Chisel Blade.

Root cause (FDA determination)

Employee error

Action the firm took

DePuy Synthes sent an Urgent Notice Medical Device Recall letter dated June 24, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Recipients were asked to check inventory and return affected devices along with the completed response form. If you have any questions, please call 610-719-5450 or contact your DePuy Synthes Sales Consultant.

Recalling firm

Firm: Synthes (USA) Products LLC
Address: 1301 Goshen Pkwy, West Chester, Pennsylvania 19380-5986

Distribution

Distribution pattern: US Distribution to the states of : NJ, VA, OH, IN, MI, FL, WI, CA, TN, MD, NC, WA, UT, ID, MO, NV and KS.

Timeline

Recall initiated: 2015-06-24
Posted by FDA: 2015-07-16
Terminated: 2016-08-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #138343. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.