Z-1949-2016Class II

LCP Dia-Meta Volar Distal Radius Plate 15 H Shaft/LT-Sterile; Indicated for fractures, osteotomies, and...

Name: Z-1949-2016 LCP Dia-Meta Volar Distal Radius Plate 15 H Shaft/LT-Sterile; Indicated for fractures, osteotomies, and...
Creator: Synthes (USA) Products LLC
Published: 2016-05-02
License: https://open.fda.gov/license/

Synthes (USA) Products LLC / initiated 2016-05-02 / Terminated / root cause: labeling and UDI

FDA source

Synthes (USA) Products LLC began a recall of LCP Dia-Meta Volar Distal Radius Plate 15 H Shaft/LT-Sterile; Indicated for fractures, osteotomies, and non-unions of the radius and other small bones on 2016-05-02. FDA classified it as Class II and gives the reason as "Product incorrectly packaged. The labels on the outside of the box and on the LCP Dia-Meta Volar Distal Radius Plate inside the box are correct; however, the preprinted box which contains the LCP-Dia-Meta Volar Distal...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1949-2016
Classification: Class II
Status: Terminated
Initiated: 2016-05-02
Posted: 2016-06-10
Terminated: 2016-12-09
Recalling firm: Synthes (USA) Products LLC
Product: LCP Dia-Meta Volar Distal Radius Plate 15 H Shaft/LT-Sterile; Indicated for fractures, osteotomies, and non-unions of the radius and other small bones.
Product code: HRS Plate, Fixation, Bone
Reason for recall: Product incorrectly packaged. The labels on the outside of the box and on the LCP Dia-Meta Volar Distal Radius Plate inside the box are correct; however, the preprinted box which contains the LCP-Dia-Meta Volar Distal Radius Plate is incorrect. The box is preprinted for a 4.5 mm LCP Condylar Plate - Distal Femur.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: DePuy Synthes sent out an Urgent Notice to customers informing them of a package mixup and the impact it could have on users. Customers were asked to evaluate their inventory and immediately remove the affected lot (9890811) from stock. Customers were asked to call DePuy Synthes at 1800-479-6329 to obtain a Return Authorization Number for return of the affected product, fill out the verification section of the letter and mail with the product to: Credit/Returns, DePuy Synthes, 1101 Synthes Avenue, Monument, CO 80132. Any questions, they were said to call 610-719-5450 or to contact their DePuy Synthes Sales Consultant.
Quantity in commerce: 6 units
Distribution: Distributed to one customer: Colorado
Product codes and lots: Lot Number 9890811, Catalog ID 02.110.115S

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1949-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1949-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-22	2016-06-10

Product code HRS

K070946Class IISynthes Lcp Diaphyseal-Metaphyseal (Dia-Meta) Volar Distal Radius PlatesSynthes (Usa) / cleared 2007-06-06

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)