Recall Z-2106-2017— MEDLINE INDUSTRIES INC
Class II · Terminated
Class II FDA medical device recall by MEDLINE INDUSTRIES INC, initiated 2016-12-14, terminated 2019-07-09. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: 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..
- Recalling firm
- MEDLINE INDUSTRIES INC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-12-14
- Terminated
- 2019-07-09
- Firm location
- Northfield, IL, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.