CLASS II ONGOING Device recall · Reported 13 Nov 2024 · FDA Enforcement Report
DeRoyal Children's Orthopedic Tracepack recalled by DeRoyal Industries
DeRoyal Industries is recalling DeRoyal Children's Orthopedic Tracepack, 89-9349-06, distributed nationwide in the US. The recall was initiated on 3 Oct 2024 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-0308-2025
- FDA event ID
- 95509
- Recalling firm
- DeRoyal Industries, Powell, TN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 3 Oct 2024
- FDA classified
- 5 Nov 2024
- Reported
- 13 Nov 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 3 Oct 2024 | Recall initiated by company | |
| 5 Nov 2024 | Classified by FDA | +33 days |
| 13 Nov 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
DeRoyal is recalling certain lots of surgical procedure pack products that contain a Stryker SafeAir Smoke Evacuation Pencil. The recall is due to Stryker receiving reports that the pencil is activating without manual input when plugged into a power source or remains active after buttons are released.
Product as listed by the FDA
DeRoyal CHILDREN'S ORTHOPEDIC TRACEPACK, 89-9349-06
Where it was distributed
US Nationwide distribution in the state of OH.
Questions about this recall
Is DeRoyal Children's Orthopedic Tracepack, 89-9349-06 recalled?
Yes. DeRoyal Industries recalled DeRoyal Children's Orthopedic Tracepack, 89-9349-06 on 3 Oct 2024. The recall is Class II and its status is Ongoing. Recall number Z-0308-2025.
Why was it recalled?
DeRoyal is recalling certain lots of surgical procedure pack products that contain a Stryker SafeAir Smoke Evacuation Pencil. The recall is due to Stryker receiving reports that the pencil is activating without manual input when plugged into a power source or remains active after buttons are released.
Which lots are affected?
UDI/ DI 00749756917292 (each), 50749756917297 (case): Lot Numbers: lot 58828011 exp 11/1/2024; lot 59098364 exp 1/1/2026; lot 59259658 exp 7/1/2025; lot 59839687 exp 11/1/2025
Where was it sold?
US Nationwide distribution in the state of OH.
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 |