AVS Aria Cage, Catalog Number 48753212 Product Usage: The Stryker Spine AVS ARIA 1M PEEK Spacers are intervertebral body fusion devices indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1 . The AVS ARIA TM PEEK Spacers are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine.
Recall
- Recall Number
- Z-0092-2019
- Event Number
- 80971
- Firm
- Stryker Spine
- FEI Number
- 3007331558
- Product Code
- MAX
- Status
- Terminated
- Root Cause
- Error in labeling
- Initiated
- August 13, 2018
- Terminated
- May 23, 2019
- Address
- 2 Pearl Ct, Allendale, NJ, 07401-1611
Description
AVS Aria Cage, Catalog Number 48753212 Product Usage: The Stryker Spine AVS ARIA 1M PEEK Spacers are intervertebral body fusion devices indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1 . The AVS ARIA TM PEEK Spacers are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine.
The anterior and posterior markers on the cage were on the incorrect/opposite sides of the cage.
Product Recall notification letters dated 8/9/18 were distributed to Branch Managers instructing them to: Regional Sales Managers and Agency Principals are ultimately responsible for the following: 1. Examine your inventory and hospital I health care facility locations to identify any AVS ARIA cages with Catalog Number referenced above. 2. If there is any product located at a Health Care Facility I Hospital or end user, the branch/agency must coordinate with a sales representative or Branch/Agency personnel to retrieve the product from the Health Care Facility I Hospital or end user. When retrieving product located at a Health Care Facility I Hospital or end user, the sales representative must do the following: Deliver the Health Care Facility Recall Notification letter to the Health Care Facility I Hospital Representative that the sales representative is retrieving the product from. Have the Health Care Facility I Hospital Representative fill out and sign the Product Recall Acknowledgement Form (attached to Health Care Facility Notification letter). Return the affected products retrieved and the completed Product Recall Acknowledgement Form to the branch/agency personnel responsible for executing the recall. 3. Use Customer Response Form to reconcile any affected product listed above. Complete Customer Response Form even if there is no effected product identified. 4. Within 5 days of receipt of this notice, the branch/agency personnel responsible for executing the recall must send completed and signed the Customer Response Form and the Product Acknowledgement Forms (from the Health Care Facilities) if applicable to Stryker Spine via: email: [email protected] All forms must filled out completely and all information must be reconciled accurately 5. Within 5 days of receipt of this notice, mail any affected product via FedEx Acct # 346869500 to: Attn: Christa Joisil - Regulatory Compliance Stryker Spine, 59 Route 17S All
US Nationwide in the states: CA, FL, GA, MI, MN, NJ, NM, and OR
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