CLASS II ONGOING Device recall · Reported 21 Dec 2022 · FDA Enforcement Report
DeRoyal KIT Total HIP recalled by DeRoyal Industries
DeRoyal Industries is recalling DeRoyal KIT Total HIP, distributed in 23 states. The recall was initiated on 3 Nov 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0627-2023
- FDA event ID
- 91134
- Recalling firm
- DeRoyal Industries, Powell, TN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 3 Nov 2022
- FDA classified
- 15 Dec 2022
- Reported
- 21 Dec 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 3 Nov 2022 | Recall initiated by company | |
| 15 Dec 2022 | Classified by FDA | +42 days |
| 21 Dec 2022 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
Product as listed by the FDA
DeRoyal KIT TOTAL HIP, REF 89-8861.07
Where it was distributed
US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi
AlabamaArizonaConnecticutFloridaGeorgiaIllinoisIndianaKansasLouisianaMassachusettsMichiganMinnesotaMissouriMississippiNorth CarolinaNew JerseyNew YorkOhioPennsylvaniaTennessee
Questions about this recall
Is DeRoyal KIT Total HIP recalled?
Yes. DeRoyal Industries recalled DeRoyal KIT Total HIP on 3 Nov 2022. The recall is Class II and its status is Ongoing. Recall number Z-0627-2023.
Why was it recalled?
DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
Which lots are affected?
Lot Numbers: Lot 56390773 exp 6/1/2026; Lot 56617464 exp 6/1/2026; Lot 57085981 exp 10/1/2026
Where was it sold?
US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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Other Hip & Knee Implants recalls
All 3,097| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Nitrosamine Impurity | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Lead & Heavy Metals | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |