OPTETRAK Inset Patella (Exactech) – packaging problem (2024)
Improper vacuum packaging can potentially compromise the sterility of medical implant components.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
OPTETRAK Inset Patella, Item Numbers: a) 200-05-23, 23MM; b) 200-05-26, 26MM; c) 200-05-29, 29MM
Brand
Exactech, Inc.
Lot Codes / Batch Numbers
a) 200-05-23, UDI/DI 10885862039835, Lot Numbers: b) 200-05-26, UDI/DI 10885862039842, Lot Numbers: c) 200-05-29, UDI/DI 10885862039859, Lot Numbers:
Products Sold
a) 200-05-23, UDI/DI 10885862039835, Lot Numbers: b) 200-05-26, UDI/DI 10885862039842, Lot Numbers: c) 200-05-29, UDI/DI 10885862039859, Lot Numbers:
Exactech, Inc. is recalling OPTETRAK Inset Patella, Item Numbers: a) 200-05-23, 23MM; b) 200-05-26, 26MM; c) 200-05-29, 2 due to Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum b. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.
Recommended Action
Per FDA guidance
Exactech issued an URGENT VOLUNTARY MEDICAL DEVICE RECALL to its sales representatives on 04/12/2024. The notice explained the issue with the device, clinical impact (risk), and requested the following: Actions to be Taken " Review this notification thoroughly. " Immediately discontinue use and quarantine any affected product. " Send all affected product back to Exactech as outlined in the attached Recall Confirmation Form . The firm notified the surgeons, hospitals, and healthcare professionals on 04/18/2024. That notice also explained the issue, clinical impact (risk) and requested the following: Actions to be Taken " Review this notification thoroughly. " Immediately discontinue use and quarantine any affected product. " Contact your Exactech Representative. Your local agent will help determine if you have any remaining affected product and remove from your 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