Recall Z-2910-2018— Stryker Leibinger GmbH & Co. KG
Class II · Terminated
Class II FDA medical device recall by Stryker Leibinger GmbH & Co. KG, initiated 2018-06-22, terminated 2019-07-08. It names one FDA 510(k) clearance: K120352. Product: AXS PP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01540S, for use on the cranium. Reason: After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised..
- Recalling firm
- Stryker Leibinger GmbH & Co. KG
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-06-22
- Terminated
- 2019-07-08
- Firm location
- Freiburg Im Breisgau, N/A, Germany
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
AXS PP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01540S, for use on the cranium
Reason for recall
After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
Data sourced from openFDA. This site is unofficial and independent of the FDA.