CLASS II ONGOING Device recall · Reported 13 Apr 2022 · FDA Enforcement Report
Total Knee Pack - Surgical Kit recalled by Stradis Medical
Stradis Medical is recalling Total Knee Pack - Surgical Kit, distributed nationwide in the US. The recall was initiated on 25 Feb 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-0864-2022
- FDA event ID
- 89671
- Recalling firm
- Stradis Medical, Peachtree Corners, GA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 25 Feb 2022
- FDA classified
- 4 Apr 2022
- Reported
- 13 Apr 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Hip & Knee Implants
Timeline
| 25 Feb 2022 | Recall initiated by company | |
| 4 Apr 2022 | Classified by FDA | +38 days |
| 13 Apr 2022 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit.
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
Total Knee Pack - Surgical Kit
Where it was distributed
US Nationwide distribution in the states of IN, TX, and PA.
Questions about this recall
Is Total Knee Pack - Surgical Kit recalled?
Yes. Stradis Medical recalled Total Knee Pack - Surgical Kit on 25 Feb 2022. The recall is Class II and its status is Ongoing. Recall number Z-0864-2022.
Why was it recalled?
The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit.
Which lots are affected?
SKU/Part Number 570-2676; UDI H65257026760 Lot Numbers: 20156461673, 20171461909, 20174462304, 20239463246, 20342468026, 21130473544, 21286478854, 21326479944, 22005482064
Where was it sold?
US Nationwide distribution in the states of IN, TX, and PA.
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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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 |