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U.S. Department of Health and Human Services

Class 2 Device Recall OPTETRAK

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 Class 2 Device Recall OPTETRAKsee related information
Date Initiated by FirmApril 18, 2024
Date PostedJune 18, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2157-2024
Recall Event ID 94409
510(K)NumberK160484 K932690 K933610 
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
ProductOPTETRAK Inset Patella, Item Numbers: a) 200-05-23, 23MM; b) 200-05-26, 26MM; c) 200-05-29, 29MM
Code Information 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:
Recalling Firm/
Manufacturer		 Exactech, Inc.
2320 Nw 66th Ct
Gainesville FL 32653-1630
For Additional Information Contact
352-377-1140
Manufacturer Reason
for Recall		Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.
FDA Determined
Cause 2		Under Investigation by firm
ActionExactech 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.
DistributionWorldwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = JWH
510(K)s with Product Code = JWH
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