CLASS II Device recall · Reported 17 Jun 2015 · FDA Enforcement Report
Extentrac Elite product brochure DCN: 13 recalled
Advanced Back Technologies is recalling Extentrac Elite product brochure DCN: 13-001, 09-001 (Powered decompression table, for, distributed nationwide in the US. The recall was initiated on 13 May 2015 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-1717-2015
- FDA event ID
- 71058
- Recalling firm
- Advanced Back Technologies, Hauppauge, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 May 2015
- FDA classified
- 5 Jun 2015
- Reported
- 17 Jun 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 13 May 2015 | Recall initiated by company | |
| 5 Jun 2015 | Classified by FDA | +23 days |
| 17 Jun 2015 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Item is marketed for use in patients weighing up to 350 lbs, but the device was only approved for use in patients up to 300 lbs
Product as listed by the FDA
Extentrac Elite product brochure DCN: 13-001, 09-001 (Powered decompression table, for traction)
Where it was distributed
Worldwide Distribution - US including CA, FL, NJ, TX, WA, Internationally: Korea, Russia, Kuwait, Canada, Greece, Lebanon, Turkey, Egypt, Saudi Arabia, China, Armenia, Azerbaijan, Australia.
Questions about this recall
Is Extentrac Elite product brochure DCN: 13-001, 09-001 (Powered decompression table, for recalled?
Yes. Advanced Back Technologies recalled Extentrac Elite product brochure DCN: 13-001, 09-001 (Powered decompression table, for on 13 May 2015. The recall is Class II and its status is Terminated. Recall number Z-1717-2015.
Why was it recalled?
Item is marketed for use in patients weighing up to 350 lbs, but the device was only approved for use in patients up to 300 lbs
Which lots are affected?
Serial Numbers: 005, 006, 011, 017, 019, 0701101, 07071003, 07071004, 08031005, 08081006, 08091007, 09061009, 09091010, 09101011, 09101012, 10021014, 10031015, 10091017, 10121019, 11051020, 11061021, 11071022, 11091023, 12011026, 12081028, 13021028, 12091029, 12091030, 12121032, 13011033, 13101034, 13071037, 13031035, 14011038, 14041036 and 14061038
Where was it sold?
Worldwide Distribution - US including CA, FL, NJ, TX, WA, Internationally: Korea, Russia, Kuwait, Canada, Greece, Lebanon, Turkey, Egypt, Saudi Arabia, China, Armenia, Azerbaijan, Australia.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Advanced Back Technologies
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Extentrac Elite User Manual DCN recalled by Advanced Back Technologies | Advanced Back Technologies | Other | Nationwide |
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