Recall Z-0679-2022— Wright Medical Technology, Inc.
Class II · Terminated
Class II FDA medical device recall by Wright Medical Technology, Inc., initiated 2022-02-09, terminated 2024-01-25. It names one FDA 510(k) clearance: K061808. Product: The DARCO¿ Locking Bone Plate System is designed with rhombus (parallelogram) plates of biocompatible titanium. The plates use either 2.7mm or 3.5mm screws which intersect each other in pairs. The drill holes of the plates are aligned to assure the screws do not touch. The various plates model numbers differ from each other through among other things different curvatures, material strengths, lengths, number of plate holes and through different grades and bridge widths. Reason: Product was labelled with the incorrect manufacturing and distribution dates..
- Recalling firm
- Wright Medical Technology, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2022-02-09
- Terminated
- 2024-01-25
- Firm location
- Memphis, TN, 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
The DARCO¿ Locking Bone Plate System is designed with rhombus (parallelogram) plates of biocompatible titanium. The plates use either 2.7mm or 3.5mm screws which intersect each other in pairs. The drill holes of the plates are aligned to assure the screws do not touch. The various plates model numbers differ from each other through among other things different curvatures, material strengths, lengths, number of plate holes and through different grades and bridge widths
Reason for recall
Product was labelled with the incorrect manufacturing and distribution dates.
Data sourced from openFDA. This site is unofficial and independent of the FDA.