Recall Z-0786-2022— Wright Medical Technology, Inc.
Class II · Terminated
Class II FDA medical device recall by Wright Medical Technology, Inc., initiated 2022-02-15, terminated 2022-10-05. It names one FDA 510(k) clearance: K090692. Product: Wright Medical Technology, Inc. ORTHOLOC Non-Locking Screw 2mm x 8mm, REF 5201120008, non-sterile, a component of the ORTHOLOC 2.0/2.4 Plate System.. Reason: An incorrect screw is packaged in the product, which contains a locking screw instead of a non-locking screw..
- Recalling firm
- Wright Medical Technology, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2022-02-15
- Terminated
- 2022-10-05
- 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
Wright Medical Technology, Inc. ORTHOLOC Non-Locking Screw 2mm x 8mm, REF 5201120008, non-sterile, a component of the ORTHOLOC 2.0/2.4 Plate System.
Reason for recall
An incorrect screw is packaged in the product, which contains a locking screw instead of a non-locking screw.
Data sourced from openFDA. This site is unofficial and independent of the FDA.