Z-2087-2013Class II

Synthes 2.4 VA-LCP 2 CLMN VLR DSTL Radius PL 7H HD/3H Shaft/Right

Name: Z-2087-2013 Synthes 2.4 VA-LCP 2 CLMN VLR DSTL Radius PL 7H HD/3H Shaft/Right
Creator: Synthes USA HQ, Inc.
Published: 2013-07-30
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2013-07-30 / Terminated / root cause: manufacturing process

FDA source

Synthes USA HQ, Inc. began a recall of 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... on 2013-07-30. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2087-2013
Classification: Class II
Status: Terminated
Initiated: 2013-07-30
Posted: 2013-08-26
Terminated: 2015-05-21
Recalling firm: Synthes GmbH
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.
Product code: HRS Plate, Fixation, Bone
Reason for recall: 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 tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 11
Distribution: USA Nationwide Distribution in the states of FL, GA, NC, OH, KY, NJ, ID, IN, and MN.
Product codes and lots: Part No. 02.111.730, with Lot No. 3614792

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2087-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2087-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-04	2013-08-26

Product code HRS

K083694Class IISynthes (USA) 2.4 Mm Va-Lcp Two Column Volar Distal Radius PlatesSynthes (Usa) / cleared 2009-03-06

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)