12 mm Distraction Pin — Class II medical device recall Z-2107-2017
Terminated recall by MEDLINE INDUSTRIES INC, reported 2017-05-24, distributed nationwide. Product's non-conformity involves the integrity of the seal in the sterile packaging. It is possible that the
| Recall number | Z-2107-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | MEDLINE INDUSTRIES INC, Northfield, IL, United States |
| Recall initiated | 2016-12-14 |
| Classified | 2017-05-17 |
| Reported by FDA | 2017-05-24 |
| Terminated | 2019-07-09 |
| Distributed | Nationwide (US) |
| Quantity | 300 individual |
| Reason classes | sterility, packaging |
| Lot numbers | 136780 |
| Model numbers | MDS9091212B |
Product
12 mm Distraction Pin, Blunt 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2107-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.