Class II — MEDLINE INDUSTRIES INC
| Recalling firm | Medline Industries, LP |
|---|---|
| Registered facility | View this company's 31 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| 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. |
| 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. |
| Quantity | 1031 individual packs |
| Distribution | Nationwide Distribution |
| Initiated | 2016-12-14 |
| Classified | 2017-05-17 |
| Terminated | 2019-07-09 |
| Recall number | Z-2106-2017 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — MEDLINE INDUSTRIES INC (Z-2106-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/76298/
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