1) ACS Spine Pack 2) ACS Lumbar/Back Set Up Tray
Recall
- Recall Number
- Z-1036-2022
- Event Number
- 89868
- Firm
- American Contract Systems, Inc.
- FEI Number
- 3003419114
- Product Code
- OJG
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- March 22, 2022
- Address
- 2610 Ne Industrial Dr, Ste 220, Kansas City, MO, 64117-2648
Description
1) ACS Spine Pack 2) ACS Lumbar/Back Set Up Tray
Product was sterilized with a higher than specification EO concentration.
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 [email protected], even if you do not have product inventory.
US Nationwide distribution in the states of IL, MO, NE, and TX.
72 packs