MEDLINE INDUSTRIES INC recalls 16 mm [or 18 mm] Distraction Pin, Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 6…

Recall date

December 14, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2104-2017

FDA classification

Class II

Brand / firm

MEDLINE INDUSTRIES INC

Sold / distributed

Nationwide Distribution

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

16 mm [or 18 mm] Distraction Pin, 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.