Z-2104-2017 Class II Terminated
FDA device recall Z-2104-2017 was initiated by MEDLINE INDUSTRIES INC on Dec 14, 2016 and is designated Class II. 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… The recall status is terminated (terminated Jul 9, 2019). Affected quantity: 2,112 individual packs.
Recall Details
- Product Type
- Devices
- Report Date
- May 24, 2017
- Initiation Date
- Dec 14, 2016
- Termination Date
- Jul 9, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,112 individual packs
Product Description
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.
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.
Distribution Pattern
Nationwide Distribution
Code Information
16 mm Pin: Item# MDS9091212; Lots #136469, 136754 | 18 mm Pin: Item# MDS9091818; Lot #136470
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2104-2017
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026