FDA Device recall Z-0240-2016
DeRoyal Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Solution, Catalog No. 8630, Lot Nos: 2016-09EE: TOTAL KNEE A & B,…
- FDA Device
- Class II
- terminated
- Published 2015-11-18
On 2015-11-18 the FDA classified a Class II recall of DeRoyal Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Solution, Catalog No. 8630, Lot Nos: 2016-09EE: TOTAL KNEE A & B,… by Deroyal Industries, citing 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 d….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0240-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-08-31 |
| Published | 2015-11-18 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Deroyal Industries |
| Distribution | AR, FL, MN, NJ, OH, OK, SC |
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.
Identifiers
| code_info | REF 89-4561.11, Lot numbers: 38198163, 38276045, 38276045; REF 89-4562.12, Lot Number 38345071; REF 89-3101.04, Lot Nu…REF 89-4561.11, Lot numbers: 38198163, 38276045, 38276045; REF 89-4562.12, Lot Number 38345071; REF 89-3101.04, Lot Number 38276230; REF 89-7744.03, Lot Number 38229177; REF 89-8194.02, Lot Number 38245020; REF 89-8439.01, Lot Number 38317548; REF 50-12160.17, Lot Number 38247391; REF 50-12602.09, Lot Number 38345266; REF 89-8381.01, Lot Number 38085071 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0240-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.