CLASS II ONGOING Device recall · Reported 18 May 2022 · FDA Enforcement Report
ACS Spine Pack ACS Lumbar/Back Set Up Tray recalled
American Contract Systems is recalling ACS Spine Pack ACS Lumbar/Back Set Up Tray, distributed nationwide in the US. The recall was initiated on 22 Mar 2022 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-1036-2022
- FDA event ID
- 89868
- Recalling firm
- American Contract Systems, Kansas City, MO
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 22 Mar 2022
- FDA classified
- 6 May 2022
- Reported
- 18 May 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Spinal Implants
Timeline
| 22 Mar 2022 | Recall initiated by company | |
| 6 May 2022 | Classified by FDA | +45 days |
| 18 May 2022 | 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
Product was sterilized with a higher than specification EO concentration.
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
1) ACS Spine Pack 2) ACS Lumbar/Back Set Up Tray
Where it was distributed
US Nationwide distribution in the states of IL, MO, NE, and TX.
Questions about this recall
Is ACS Spine Pack ACS Lumbar/Back Set Up Tray recalled?
Yes. American Contract Systems recalled ACS Spine Pack ACS Lumbar/Back Set Up Tray on 22 Mar 2022. The recall is Class II and its status is Ongoing. Recall number Z-1036-2022.
Why was it recalled?
Product was sterilized with a higher than specification EO concentration.
Which lots are affected?
1) ACS Spine Pack - Model LOSP35D, Lot 966221; UDI 00191072154613 2) ACS Lumbar/Back Set Up Tray - Model SALB85AG, Lot 973221; UDI: 00191072127280
Where was it sold?
US Nationwide distribution in the states of IL, MO, NE, and TX.
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 American Contract Systems
All 210| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Convenience Kits, CV B PACK recalled by American Contract Systems | American Contract Systems | Foreign Material | Nationwide |
| Device | CLASS II | Convenience Kit, CV B PACK recalled by American Contract Systems | American Contract Systems | Foreign Material | Nationwide |
| Device | CLASS II | Convenience Kit, CV B PACK recalled by American Contract Systems | American Contract Systems | Foreign Material | Nationwide |
| Device | CLASS II | Convenience Kit, D & C PACK recalled by American Contract Systems | American Contract Systems | Foreign Material | Nationwide |
| Device | CLASS II | medical procedure kits and trays labeled as: Crani Pack recalled | American Contract Systems | Sterility | IA, MN, MO |
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 |