Recall Z-1634-2015— Stryker Howmedica Osteonics Corp.
Class II · Terminated
Class II FDA medical device recall by Stryker Howmedica Osteonics Corp., initiated 2014-08-15, terminated 2018-01-05. It names 4 FDA 510(k) clearances: K042343, K030978, K974556 and 1 more. Product: Stryker Orthopaedics Scorpio femoral component. Howmedica Osteonics Corp., A subsidiary of Stryker Corporation Made in USA Sterile. For use in total reconstructive replacement of the knee joint.. Reason: The peel strength of the inner blister may have been below internal validated requirements. The strength of the seal is directly related to long term shelf life of the sterile barrier..
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-08-15
- Terminated
- 2018-01-05
- Firm location
- Mahwah, NJ, United States
510(k) clearances named in this recall
4 on FDA's record- K042343 — SCORPIO NRG KNEE SYSTEM
- K030978 — SCORPIO NRG KNEE SYSTEM
- K974556 — OSTEONICS SCORPIO POSTERIOR CRUCIATE RETAINING TOTAL KNEE SYSTEM
- K962152 — OSTEONICS SCORPIO POSTERIORLY STABILIZED TOTAL KNEE SYSTEM
K-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
Stryker Orthopaedics Scorpio femoral component. Howmedica Osteonics Corp., A subsidiary of Stryker Corporation Made in USA Sterile. For use in total reconstructive replacement of the knee joint.
Reason for recall
The peel strength of the inner blister may have been below internal validated requirements. The strength of the seal is directly related to long term shelf life of the sterile barrier.
Data sourced from openFDA. This site is unofficial and independent of the FDA.