Device 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.
Z-2105-2017
Product summary
- Event
- Event 76298
- Status
- Terminated
- Classification
- Class II
- Quantity
- 49 individual packs
- Official record key
device-enforcement:Z-2105-2017
Official wording
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 information: Item# MDS9091010; Lots #133115, 136754
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Labeling or packaging
packaging. It is possible that the seal on the sterile packaging has been compromised
-
Sterility assurance
loss of sterility