Recall Z-0240-2016— DeRoyal Industries Inc
Class II · Terminated
Class II FDA medical device recall by DeRoyal Industries Inc, initiated 2015-08-31, terminated 2016-04-12. FDA's recall record names no specific 510(k) clearance for this event. Product: DeRoyal Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Solution, Catalog No. 8630, Lot Nos: 2016-09EE: TOTAL KNEE A & B, REF 89-4561.11; TOTAL HIP A & B, REF 89-4562.12; PODIATRY TRAY, REF 89-3101.04; KNEE SCOPE PACK, REF 89-7744.03; KNEE PACK, REF 89-8194.02; BEACH CHAIR PACK, REF 89-8439.01; TOTAL JOINT, REF 50-12160.17; BACK TRAY, REF 50-12602.09; PACEMAKER PACK, REF 89-8381.01;. Reason: Custom Sterile Surgical kits contain 3M DuraPrep (TM) Surgical Solution, Catalog Number 8630, Lot Number 2016-09EE which was recalled due to unintended exposure to the sterilant during package sterilization..
- Recalling firm
- DeRoyal Industries Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-08-31
- Terminated
- 2016-04-12
- Firm location
- Powell, TN, United States
Product description
DeRoyal Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Solution, Catalog No. 8630, Lot Nos: 2016-09EE: TOTAL KNEE A & B, REF 89-4561.11; TOTAL HIP A & B, REF 89-4562.12; PODIATRY TRAY, REF 89-3101.04; KNEE SCOPE PACK, REF 89-7744.03; KNEE PACK, REF 89-8194.02; BEACH CHAIR PACK, REF 89-8439.01; TOTAL JOINT, REF 50-12160.17; BACK TRAY, REF 50-12602.09; PACEMAKER PACK, REF 89-8381.01;
Reason for recall
Custom Sterile Surgical kits contain 3M DuraPrep (TM) Surgical Solution, Catalog Number 8630, Lot Number 2016-09EE which was recalled due to unintended exposure to the sterilant during package sterilization.
Data sourced from openFDA. This site is unofficial and independent of the FDA.