CLASS II ONGOING Device recall · Reported 8 Feb 2023 · FDA Enforcement Report
Non-sterile procedural trays labeled as Theda Clark Total Knee Cds recalled
MEDLINE INDUSTRIES, LP - Northfield is recalling Non-sterile procedural trays labeled as Theda Clark Total Knee Cds, distributed nationwide in the US. The recall was initiated on 17 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-1034-2023
- FDA event ID
- 91387
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 17 Nov 2022
- FDA classified
- 27 Jan 2023
- Reported
- 8 Feb 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Hip & Knee Implants
Timeline
| 17 Nov 2022 | Recall initiated by company | |
| 27 Jan 2023 | Classified by FDA | +71 days |
| 8 Feb 2023 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the outer foil layer causing a breach in the sterile packaging.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Non-sterile procedural trays labeled as THEDA CLARK TOTAL KNEE CDS, 1 per case
Where it was distributed
US Nationwide distribution in the states of AR, MD, WA, WI.
Questions about this recall
Is Non-sterile procedural trays labeled as Theda Clark Total Knee Cds recalled?
Yes. MEDLINE INDUSTRIES, LP - Northfield recalled Non-sterile procedural trays labeled as Theda Clark Total Knee Cds on 17 Nov 2022. The recall is Class II and its status is Ongoing. Recall number Z-1034-2023.
Why was it recalled?
Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the outer foil layer causing a breach in the sterile packaging.
Which lots are affected?
Item Number: CDSOPP508AG, UDI/GTIN Case: 40195327145140, UDI/GTIN Each: 10195327145149, Lot Number: 22HBO323
Where was it sold?
US Nationwide distribution in the states of AR, MD, WA, WI.
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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|---|---|---|---|---|---|
| Device | CLASS I | Medline medical convenience kits labeled as recalled | MEDLINE INDUSTRIES, LP - Northfield | Device Malfunction | 6 states |
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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 |