FDA Device recall Z-2104-2017
16 mm [or 18 mm] Distraction Pin, Qty: 1 per pack
- FDA Device
- Class II
- terminated
- Published 2017-05-24
On 2017-05-24 the FDA classified a Class II recall of 16 mm [or 18 mm] Distraction Pin, Qty: 1 per pack by Medline Industries, citing 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 los….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2104-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-12-14 |
| Published | 2017-05-24 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Medline Industries |
| Distribution | US |
Product
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
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.
Identifiers
| code_info | 16 mm Pin: Item# MDS9091212; Lots #136469, 136754 | 18 mm Pin: Item# MDS9091818; Lot #136470 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2104-2017%22
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