FDA Enforcement
Class II
Terminated
10 mm Distraction Pin, Aggressive Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA Distraction Pin is designed for Anterior Cervical Fusion Procedures. Use with vertebral body distraction instruments. It is intended as a temporary fixation screw utilized during cervical spine procedures.
Recall: Z-2105-2017
·
Reported May 24, 2017
Enforcement
- Recall Number
- Z-2105-2017
- Event ID
- 76298
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- MEDLINE INDUSTRIES INC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 24, 2017
- Initiation Date
- December 14, 2016
- Classification Date
- May 17, 2017
- Termination Date
- July 9, 2019
- Address
- 3 Lakes Dr, Northfield, IL, 60093-2753, United States
Description
10 mm Distraction Pin, Aggressive Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA Distraction Pin is designed for Anterior Cervical Fusion Procedures. Use with vertebral body distraction instruments. It is intended as a temporary fixation screw utilized during cervical spine procedures.
Reason
Product's non-conformity involves the integrity of the seal in the sterile packaging. It is possible that the seal on the sterile packaging has been compromised resulting in a loss of sterility of the medical device contained within.
Code Info
Item# MDS9091010; Lots #133115, 136754
Distribution
Nationwide Distribution
Quantity
49 individual packs