Z-0489-2007

LCP Volar Distal Radius Plate Extra Articular 4H HD-RT-Long, LCP Volar Distal Radius Plate 2.4 mm, Catalog...

Name: Z-0489-2007 LCP Volar Distal Radius Plate Extra Articular 4H HD-RT-Long, LCP Volar Distal Radius Plate 2.4 mm, Catalog...
Creator: Synthes
Published: 2006-12-05
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2006-12-05 / Terminated

FDA source

Synthes began a recall of LCP Volar Distal Radius Plate Extra Articular 4H HD-RT-Long, LCP Volar Distal Radius Plate 2.4 mm, Catalog number 242.465 on 2006-12-05. The reason FDA records is "Hole is malformed, leading to reduced construct strength". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0489-2007
Status: Terminated
Initiated: 2006-12-05
Posted: 2007-01-11
Terminated: 2007-02-13
Recalling firm: Synthes GmbH
Product: LCP Volar Distal Radius Plate Extra Articular 4H HD-RT-Long, LCP Volar Distal Radius Plate 2.4 mm, Catalog number 242.465
Product code: HRS Plate, Fixation, Bone
Reason for recall: Hole is malformed, leading to reduced construct strength.
FDA root cause: Other
Action: All Sales Consultants were notified of the recall via teleconference on 12/5/06. The telephone script, part number and affected lot were communicated to the consultants during the teleconference. They were instructed to retrieve the affected product from the field.
Quantity in commerce: 11 units
Distribution: The products were shipped to medical facilities in NJ, TN, LA, and KS. The products were also shipped to sales reps in PA, SC, and CA. The product was also shipped to Canada.
Product codes and lots: Catalog number 242.465, Lot number 5373486

Product code HRS

K012114Class IISynthes Locking Distal Radius Plating SystemSynthes (Usa) / cleared 2001-09-28

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)