Z-2057-2013Class II

Synthes 2.4mm VA-LCP Two Column Volar Distal Radius Plate and Torque limiting attachment, 1.2Nm Synthes...

Name: Z-2057-2013 Synthes 2.4mm VA-LCP Two Column Volar Distal Radius Plate and Torque limiting attachment, 1.2Nm Synthes...
Creator: Synthes (USA) Products LLC
Published: 2013-05-31
License: https://open.fda.gov/license/

Synthes (USA) Products LLC / initiated 2013-05-31 / Terminated / root cause: design

FDA source

Synthes (USA) Products LLC began a recall of 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... on 2013-05-31. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2057-2013
Classification: Class II
Status: Terminated
Initiated: 2013-05-31
Posted: 2013-08-26
Terminated: 2015-09-21
Recalling firm: Synthes (USA) Products LLC
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.
Product code: HRS Plate, Fixation, Bone
Reason for recall: 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 tag: design
FDA root cause: Device Design
Action: 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.
Quantity in commerce: 119, 891
Distribution: 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.
Product codes and lots: Part number J8301-F

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2057-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2057-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-04	2013-08-26

Product code HRS

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)