American Contract Systems, Inc. 1) ACS Spine Pack 2) ACS Lumbar/Back Set Up Tray Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
1) ACS Spine Pack 2) ACS Lumbar/Back Set Up Tray
Brand
American Contract Systems, Inc.
Lot Codes / Batch Numbers
1) ACS Spine Pack - Model LOSP35D, Lot 966221, UDI 00191072154613 2) ACS Lumbar/Back Set Up Tray - Model SALB85AG, Lot 973221, UDI: 00191072127280
Products Sold
1) ACS Spine Pack - Model LOSP35D, Lot 966221; UDI 00191072154613 2) ACS Lumbar/Back Set Up Tray - Model SALB85AG, Lot 973221; UDI: 00191072127280
American Contract Systems, Inc. is recalling 1) ACS Spine Pack 2) ACS Lumbar/Back Set Up Tray due to Product was sterilized with a higher than specification EO concentration.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Product was sterilized with a higher than specification EO concentration.
Recommended Action
Per FDA guidance
A customer letter dated 04/05/2022 was issued to impacted consignees. The letter instructs the following: 1) Review your inventory and segregate affected product. This product should not be shipped out to customers. 2) Return affected product to 2610 NE Industrial Drive, Suite 220, Kansas City, MO 64120. 3) If product was already further distributed, ensure that all downstream customers are properly notified of the recall and maintain records of effectiveness. A Field Action Response Form should be completed and returned to suzanne.thomas@hyh.com, even if you do not have product inventory.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026