Recall StatusOpen, Classified
Date Initiated2023-08-22
Product Quantity20
Reason for Recall
Knee insert and acetabular system parts were swapped within inner pack prior to the product being sealed within the tray, which could result in surgeons not having the correct product for the surgery due to different anatomies (Hip vs Knee).
Firm Action
On 8/22/23, recall notices were emailed to agents who were asked to do the following:
1) Complete acknowledgement and response form and contact Customer Service at 1-800-456-8696 to place a replacement order and receive an RMA number.
2) The notice needs to be passed on to all those within your organization or to any organization where the potentially affected product has been transferred.
If you have any questions, email
[email protected]
Root Cause
Labeling Change Control
Distribution Pattern
US Nationwide distribution in the states of FL, CA, IN, HI, LA, MN, AZ, TX, NJ, PA, KS, TN, PR, SC, WA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.