CLASS II Device recall · Reported 24 May 2017 · FDA Enforcement Report
Distraction Pin, Exagg Qty: 1 per pack recalled by Medline Industries
Medline Industries is recalling Distraction Pin, Exagg Qty: 1 per pack, distributed nationwide in the US. The recall was initiated on 14 Dec 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2106-2017
- FDA event ID
- 76298
- Recalling firm
- Medline Industries, Northfield, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Dec 2016
- FDA classified
- 17 May 2017
- Reported
- 24 May 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Spinal Implants
Timeline
| 14 Dec 2016 | Recall initiated by company | |
| 17 May 2017 | Classified by FDA | +154 days |
| 24 May 2017 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
Nationwide Distribution
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Item# MDS9091414A; Lots #136190
Where was it sold?
Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
4 other products · FDA event 76298| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Distraction Pin, Titanium, Qty: 1 per pack recalled | Medline Industries | Sterility | Nationwide | |
| CLASS II | Distraction Pin, Blunt Qty: 1 per pack recalled by Medline Industries | Medline Industries | Sterility | Nationwide | |
| CLASS II | [or] Distraction Pin, Qty: 1 per pack recalled by Medline Industries | Medline Industries | Sterility | Nationwide | |
| CLASS II | Distraction Pin, Aggressive Qty: 1 per pack recalled | Medline Industries | Sterility | Nationwide |
More recalls from Medline Industries
All 686| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: Blood Draw Kit recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Packaging Defects | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Ortho Aspiration Kit recalled | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep DYKA1054F recalled | Medline Industries | Packaging Defects | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Arterial Line Insertion Kit recalled | Medline Industries | Sterility | Nationwide |
Other Spinal Implants recalls
All 1,157| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled | Avid Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: ENT recalled | Avid Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: A-P PACK recalled | Avid Medical | Sterility | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |