FDA Medical Device Recalls (openFDA)
Wright Medical Technology, Inc.: CROSSCHECK(R) Plating system, Utility Plate, 5-Hole, REF CCP-UTN5. Orthopedic use.
- Recall number
- Z-1497-2015
- Recalling firm
- Wright Medical Technology, Inc.
- Product
- CROSSCHECK(R) Plating system, Utility Plate, 5-Hole, REF CCP-UTN5. Orthopedic use.
- Status
- Terminated
- Initiated
- 2015-03-06
- Posted
- 2015-04-22
- Terminated
- 2018-08-05
- Reason
- The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction
- Root cause
- Nonconforming Material/Component
- Action
- Firm has initiated the recall on 03/06/2015 through written communication via Fed Ex P1 delivery to all Wright Medical Technologies distributors (hubs). Follow-up to non-responding consignees will commence 30 days after initiation. Effectiveness checks will be performed through the confirmation of returned product via a validated ERP system, a returned/signed verification form, and in the case of non-responders, a phone call, e-mail or follow up letter, depending on the region and availability of consignee.
- Quantity
- 138 units
- Distribution
- Nationwide Distribution.
- Lot, serial or model codes
- Lot Numbers: 3504933, 35049-33A, 35049-33A-1, 35049-34, 362804, 36280-4-1-A
- 510(k) numbers
- ["K132594"]
- PMA numbers
- not on file
- Product code
- HRS
- Firm FEI
- 3010667733
- Firm city
- Memphis
- Firm state
- TN
- 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