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MEDLINE INDUSTRIES INC recalls 10 mm Distraction Pin, Aggressive Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60
Recalled May 24, 2017 · FDA recall Z-2105-2017 · MEDLINE INDUSTRIES
Hazard
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. · FDA Class II
Units
49 individual packs
Sold at
Nationwide Distribution
Description
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.
Product
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.
Manufacturer(s)
MEDLINE INDUSTRIES INC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →