CLASS II Device recall · Reported 22 May 2019 · FDA Enforcement Report
Tissu-Trans Filtron recalled by Shippert Medical Technologies
Shippert Medical Technologies is recalling Tissu-Trans Filtron 500, distributed nationwide in the US. The recall was initiated on 2 Feb 2018 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-1332-2019
- FDA event ID
- 81837
- Recalling firm
- Shippert Medical Technologies, Centennial, CO
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 2 Feb 2018
- FDA classified
- 15 May 2019
- Reported
- 22 May 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Hip & Knee Implants
Timeline
| 2 Feb 2018 | Recall initiated by company | |
| 15 May 2019 | Classified by FDA | +467 days |
| 22 May 2019 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The pouch integrity of the sterile product can't be assured without a visual examination due to possibly containing a cut or hole in the pouch.
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
Tissu-Trans FILTRON 500, Catalog 3-TT-FILTRON 500, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technologies, Centennial, CO.
Where it was distributed
Distribution was nationwide, including PR. There was government/military distribution. Foreign distribution was made to Australia, Austria, Belgium, Denmark, Germany, Greece, India, Italy, Japan, Netherlands, New Zealand, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom,
Questions about this recall
Is Tissu-Trans Filtron 500 recalled?
Yes. Shippert Medical Technologies recalled Tissu-Trans Filtron 500 on 2 Feb 2018. The recall is Class II and its status is Completed. Recall number Z-1332-2019.
Why was it recalled?
The pouch integrity of the sterile product can't be assured without a visual examination due to possibly containing a cut or hole in the pouch.
Which lots are affected?
Lot numbers 61508, 61636, 61683, 61753, 61804, 61812, 61813, 61814, 61815, 61862, 61917, 61949, 61991, 62052, 62089, 62134, and 62156
Where was it sold?
Distribution was nationwide, including PR. There was government/military distribution. Foreign distribution was made to Australia, Austria, Belgium, Denmark, Germany, Greece, India, Italy, Japan, Netherlands, New Zealand, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom,
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 Shippert Medical Technologies
All 15| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Tissu-Trans Filtron recalled by Shippert Medical Technologies | Shippert Medical Technologies | Sterility | Nationwide |
| Device | CLASS II | Tissu-Trans Filtron recalled by Shippert Medical Technologies | Shippert Medical Technologies | Sterility | Nationwide |
| Device | CLASS II | Tissu-Trans MEGA recalled by Shippert Medical Technologies | Shippert Medical Technologies | Sterility | Nationwide |
| Device | CLASS II | Tissu-Trans Filtron recalled by Shippert Medical Technologies | Shippert Medical Technologies | Sterility | Nationwide |
| Device | CLASS II | Tissu-Trans Filtron recalled by Shippert Medical Technologies | Shippert Medical Technologies | Sterility | Nationwide |
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|---|---|---|---|---|---|
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| 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 |