Recall Z-0448-2022— Flower Orthopedics Corporation
Class II · Terminated
Class II FDA medical device recall by Flower Orthopedics Corporation, initiated 2021-11-02, terminated 2023-10-12. It names one FDA 510(k) clearance: K202858. Product: Flex-Thread Inserter Shaft intended for Fibula intramedullary-intended to be used with the Inserter Draw Rod and Blue Ratchet Handle in order to facilitate the insertion of the Flex-Thread Nail System- Catalog Number: 8435-1. Reason: Mating incompatibility between the Inserter Shaft and the Inserter Draw Rod causing the inserter draw rod to bind and not rotate freely as intended surgeon may be unable to complete surgery unless a second set is available.
- Recalling firm
- Flower Orthopedics Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-11-02
- Terminated
- 2023-10-12
- Firm location
- Horsham, PA, United States
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
Flex-Thread Inserter Shaft intended for Fibula intramedullary-intended to be used with the Inserter Draw Rod and Blue Ratchet Handle in order to facilitate the insertion of the Flex-Thread Nail System- Catalog Number: 8435-1
Reason for recall
Mating incompatibility between the Inserter Shaft and the Inserter Draw Rod causing the inserter draw rod to bind and not rotate freely as intended surgeon may be unable to complete surgery unless a second set is available
Data sourced from openFDA. This site is unofficial and independent of the FDA.