FDA Medical Device Recalls (openFDA)
Synthes (USA) Products LLC: 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.
- Recall number
- Z-1949-2016
- 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.
- Status
- Terminated
- Initiated
- 2016-05-02
- Posted
- 2016-06-10
- Terminated
- 2016-12-09
- Reason
- 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
- 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
- 6 units
- Distribution
- Distributed to one customer: Colorado
- Lot, serial or model codes
- Lot Number 9890811, Catalog ID 02.110.115S
- 510(k) numbers
- K070946
- PMA numbers
- not on file
- Product code
- HRS
- Firm FEI
- 3008812560
- Firm city
- West Chester
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28