FDA Medical Device Recalls (openFDA)
Synthes, Inc.: Synthes Guide Blocks for the 2 Column Plate 6 Hole Head (Volar Distal Radius Plate System). Orthopedic surgical instrument.
- Recall number
- Z-2087-2014
- Recalling firm
- Synthes, Inc.
- Product
- Synthes Guide Blocks for the 2 Column Plate 6 Hole Head (Volar Distal Radius Plate System). Orthopedic surgical instrument.
- Status
- Terminated
- Initiated
- 2014-05-29
- Posted
- 2014-07-21
- Terminated
- 2016-08-18
- Reason
- The Guide Blocks for the 2 Column Plate 6 Hole Head (Volar Distal Radius Plate System) were found to be labeled incorrectly. Part no. 03.111.600 (Right) was found in the package labeled part no. 03.111.601 (Left). The laser etching denoting the orientation on the part is correct.
- Root cause
- Process control
- Action
- An urgent field correction notification, dated May 29, 2014, was sent to end users and sales consultants which described the product, problem, and actions to be taken.
- Quantity
- 180
- Distribution
- Distribution US Nationwide and Bermuda.
- Lot, serial or model codes
- part no. 03.111.600, lot no. 10-5147, and part no. 03.111.601, lot no. 10-5147
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LXH
- Firm FEI
- 3005180112
- 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