—#119565

Product

Synthes 2.4mm VA-LCP Two Column Volar Distal Radius Plate and Torque limiting attachment, 1.2Nm Synthes VA-LCP Distal Radius System is 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: K071184, K083694, K092556
Affected lot / code info: Part number J8301-F

Why it was recalled

The firm is initiating a Field Safety Correction for the labeling of the 2.4mm VA-LCP Two Column Volar Distal Radius Plate and 1.2 Nm Torque Limiting Attachment. The US Technique guide lists 1.2Nm TLA as an option for use with the 2.4mm Variable Angle LCP (VA-LCP) Two-Column (Standard & Narrow) Volar Distal Radius Plate. The potential exists for the VA locking screw to be driven through the 2.4mm

Root cause (FDA determination)

Device Design

Action the firm took

Synthes sent an Urgent Notice: Medical Device Labeling Correction letter dated May 31, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The firm is initiating a Field Safety Correction for the labeling of the 2.4mm VA-LCP Two Column Volar Distal Radius Plate and 1.2 Nm Torque Limiting Attachment. The US Technique guide lists 1.2Nm TLA as an option for use with the 2.4mm Variable Angle LCP (VA-LCP) Two-Column (Standard & Narrow) Volar Distal Radius Plate. The potential exists for the VA locking screw to be driven through the 2.4mm VA-LCP Two Column Volar Distal Radius Plate when used with a 1.2Nm Torque Limiting Attachment. A screw that passes through the VA-LCP plate is not likely to result in a serious adverse event although should it occur, additional medical intervention during the index procedure could be needed. If you have any questions, please call (610) 719-5450, or contact your Synthes sales Consultant.

Recalling firm

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

Distribution

Distribution pattern: Nationwide Distribution including the states of AK. AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MD, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI SC, SD, TN, TX, UT, VA, VT, WA WI and WV.

Timeline

Recall initiated: 2013-05-31
Posted by FDA: 2013-08-26
Terminated: 2015-09-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #119565. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.