PlainRecalls
FDA Devices Moderate Class II Terminated

14 mm Distraction Pin, Exagg 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.

Reported: May 24, 2017 Initiated: December 14, 2016 #Z-2106-2017

Product Description

14 mm Distraction Pin, Exagg 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 for Recall

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.

Details

Recalling Firm
MEDLINE INDUSTRIES INC
Units Affected
1031 individual packs
Distribution
Nationwide Distribution
Location
Northfield, IL

Frequently Asked Questions

What product was recalled?
14 mm Distraction Pin, Exagg 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.. Recalled by MEDLINE INDUSTRIES INC. Units affected: 1031 individual packs.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on May 24, 2017. Severity: Moderate. Recall number: Z-2106-2017.