Recall Z-2244-2018— Stryker GmbH
Class II · Terminated
Class II FDA medical device recall by Stryker GmbH, initiated 2018-05-04, terminated 2020-04-27. FDA's recall record names no specific 510(k) clearance for this event. Product: Farabeuf Clamp for 3.5mm Screws PRO, Catalog # 705463. Reason: Laser etching which indicates whether the device is in compression or distraction mode appears to be on the wrong side of the lever arm.
- Recalling firm
- Stryker GmbH
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-05-04
- Terminated
- 2020-04-27
- Firm location
- Selzach, N/A, Switzerland
Product description
Farabeuf Clamp for 3.5mm Screws PRO, Catalog # 705463
Reason for recall
Laser etching which indicates whether the device is in compression or distraction mode appears to be on the wrong side of the lever arm
Data sourced from openFDA. This site is unofficial and independent of the FDA.