—#120724

Product

Synthes 2.4 VA-LCP 2 CLMN VLR DSTL Radius PL 7H HD/3H Shaft/Right Product Usage: Intended for fixation of complex intra-and extra-articular fractures and osteotomies of the distal radius and other small bones.

FDA product code: HRS — Plate, Fixation, Bone
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K083694
Affected lot / code info: Part No. 02.111.730, with Lot No. 3614792

Why it was recalled

The possibility exists that 2.4 mm VA-LCP 2 column distal radius plates from a specific lot are etched with "R" for right plate when they should be etched with "L" for left plate.

Root cause (FDA determination)

Process control

Action the firm took

Synthes GMBH 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 and immediately remove the affected product from stock. Customers were advised to complete the Verification Section at the end of the letter. For questions call 610-719-5450 or contact your Synthes Sales Consultant.

Recalling firm

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

Distribution

Distribution pattern: USA Nationwide Distribution in the states of FL, GA, NC, OH, KY, NJ, ID, IN, and MN.

Timeline

Recall initiated: 2013-07-30
Posted by FDA: 2013-08-26
Terminated: 2015-05-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #120724. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.