Claw II Polyaxial Compression System and Ortholoc 3DSI Locking Screws

510(k) K113014

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

This device is named in the recall

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK113014	Date31 Jan 2012Cleared	StatusActive

12 recalls · 3 ongoing · FDA

2 recalls, same reason
- Ongoing Z-1170-2023 FDA Class II initiated 2 Feb 2023
- Ongoing Z-1169-2023 FDA Class II initiated 2 Feb 2023
Stryker has identified an issue that impacts two specific lots of CLAW" II plates. The plates within these two lots were found to have been comingled, resulting in the incorrect product in packages. Packaging for 402S0425 incorrectly contained 40241425, and vice versa.
- Ongoing Z-0392-2022 FDA Class II initiated 3 Dec 2021
The incorrect product is contained in the packaging.
9 recalls, same reason
- Terminated Z-2604-2014 FDA Class II initiated 30 Jul 2014
- Terminated Z-2602-2014 FDA Class II initiated 30 Jul 2014
- Terminated Z-2603-2014 FDA Class II initiated 30 Jul 2014
- Terminated Z-2608-2014 FDA Class II initiated 30 Jul 2014
- Terminated Z-2605-2014 FDA Class II initiated 30 Jul 2014
- Terminated Z-2607-2014 FDA Class II initiated 30 Jul 2014
- Terminated Z-2600-2014 FDA Class II initiated 30 Jul 2014
- Terminated Z-2599-2014 FDA Class II initiated 30 Jul 2014
- Terminated Z-2601-2014 FDA Class II initiated 30 Jul 2014
Plates manufactured from an incorrect raw material.

1 jurisdiction

United States — FDA 510(k) Active

510(k)