LCP Dia-Meta Volar Distal Radius Plate 15 H Shaft/LT-Sterile recallZ-1949-2016 · Synthes (USA) Products LLC · initiated May 2, 2016
Class II Terminated All recalls posted in June 2016
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Synthes (USA) Products LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-1949-2016
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- May 2, 2016
- Posted by the FDA
- Jun 10, 2016
- Recalling firm
- Synthes (USA) Products LLC
- Quantity
- 6 units
- Product code
- HRS
- FDA submissions
- K070946
- Distribution
- Distributed to one customer: Colorado
Product description
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.
Code information (models, lots, serial numbers)
Lot Number 9890811, Catalog ID 02.110.115S
Other devices under the same FDA submission
2 devices cleared under K070946 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- LCP 02.110.007Synthes GmbH · PLATE, FIXATION, BONE1 report
- LCP 02.110.105Synthes GmbH · PLATE, FIXATION, BONE1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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