CLASS II ONGOING Device recall · Reported 21 Dec 2022 · FDA Enforcement Report
DeRoyal Spinal Fusion Pack recalled by DeRoyal Industries
DeRoyal Industries is recalling DeRoyal Spinal Fusion Pack, 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-0598-2023
- 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
- Spinal 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 SPINAL FUSION PACK, REF 89-7515.14
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 Spinal Fusion Pack recalled?
Yes. DeRoyal Industries recalled DeRoyal Spinal Fusion Pack on 3 Nov 2022. The recall is Class II and its status is Ongoing. Recall number Z-0598-2023.
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 57746997 exp 12/1/2026
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.
More recalls from DeRoyal Industries
All 226| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | DeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access recalled | DeRoyal Industries | Sterility | Nationwide |
| Device | CLASS II | DeRoyal REF 71-C5100NS Tubing, Suction, Connector; DeRoyal REF recalled | DeRoyal Industries | Foreign Material | 5 states |
| Device | CLASS II | DeRoyal AMG Suction Connector Tubing recalled by DeRoyal Industries | DeRoyal Industries | Packaging Defects | 21 states |
| Device | CLASS II | DeRoyal C-section Tracepack recalled by DeRoyal Industries | DeRoyal Industries | Other | Nationwide |
| Device | CLASS II | DeRoyal Children's General Tracepack recalled by DeRoyal Industries | DeRoyal Industries | Other | Nationwide |
Other Spinal Implants recalls
All 1,157| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: ENT recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: A-P PACK recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |