—#122357

Product

Synthes 2.4 mm LC-DCP Plate 6 Holes/51mm Product Usage: Intended for fractures, osteotomies, and replantations of small bones including the foot, ankle, and hand.

FDA product code: HRS — Plate, Fixation, Bone
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K001941
Affected lot / code info: Part No. 249.926, lot No. 8093100

Why it was recalled

A complaint was reported regarding a screw being found in a package labeled for 2.4 mm LC-DCP Plate.

Root cause (FDA determination)

Labeling mix-ups

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 affected product, problem and actions to be taken. Customers were instructed to review their inventory, immediately remove the affected product and return to Credit/Returns, Synthes. For questions call 610-719-5450.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution - USA (nationwide) including IN, NY, WA, NE, MD, TX, AL, MI, and Internationally to Canada.

Timeline

Recall initiated: 2013-07-30
Posted by FDA: 2013-11-27
Terminated: 2015-08-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #122357. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.