Recall Z-1139-2021— DeRoyal Industries Inc
Class II · Terminated
Class II FDA medical device recall by DeRoyal Industries Inc, initiated 2021-01-25, terminated 2022-07-21. It names one FDA 510(k) clearance: K842648. Product: Open Heart Pack, REF numbers: a) 89-7483.07 b) 89-7483.08 c) 89-7483.09 d) 89-7483.10 Custom surgical procedure packs including sternum saw blades.. Reason: Sternum saw blades within procedure packs are not sterile. The surgical saw blade has a green non-sterile sticker..
- Recalling firm
- DeRoyal Industries Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-01-25
- Terminated
- 2022-07-21
- Firm location
- Powell, TN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Open Heart Pack, REF numbers: a) 89-7483.07 b) 89-7483.08 c) 89-7483.09 d) 89-7483.10 Custom surgical procedure packs including sternum saw blades.
Reason for recall
Sternum saw blades within procedure packs are not sterile. The surgical saw blade has a green non-sterile sticker.
Data sourced from openFDA. This site is unofficial and independent of the FDA.