Recall Z-2600-2014— Wright Medical Technology, Inc.
Class II · Terminated
Class II FDA medical device recall by Wright Medical Technology, Inc., initiated 2014-07-30, terminated 2018-06-15. It names 3 FDA 510(k) clearances: K133715, K113014, K080295. Product: CLAW 3.5mm PLATE CHARLOTTE F&A SYSTEM, SIZE 30mm, 2 HOLE, USE WITH 3.5mm CLAW SCREW, REF 4013-0130, 1 EACH, Rx ONLY, NON STERILE Orthopedic. Reason: Plates manufactured from an incorrect raw material..
- Recalling firm
- Wright Medical Technology, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-07-30
- Terminated
- 2018-06-15
- Firm location
- Memphis, TN, United States
510(k) clearances named in this recall
3 on FDA's record- K133715 — CHARLOTTE CLAW PLATE SYSTEM
- K113014 — CLAW II POLYAXIAL COMPRESSION SYSTEM AND ORTHOLOC 3DSI LOCKING SCREWS
- K080295 — CHARLOTTE CLAW 3.5
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
CLAW 3.5mm PLATE CHARLOTTE F&A SYSTEM, SIZE 30mm, 2 HOLE, USE WITH 3.5mm CLAW SCREW, REF 4013-0130, 1 EACH, Rx ONLY, NON STERILE Orthopedic
Reason for recall
Plates manufactured from an incorrect raw material.
Data sourced from openFDA. This site is unofficial and independent of the FDA.