TCC-EZ, Total Contact Cast System, Model No. TCC2-4051
Reported: May 2, 2018 Initiated: August 18, 2017 #Z-1487-2018
Product Description
TCC-EZ, Total Contact Cast System, Model No. TCC2-4051
Reason for Recall
A quarantined lot of the devices was released for sale. Devices from this lot may experience increased exothermic reaction causing higher levels of heat output which exceed the product specifications.
Details
- Recalling Firm
- Integra LifeSciences Corp.
- Units Affected
- 250
- Distribution
- US nationwide distribution.
- Location
- Plainsboro, NJ
Frequently Asked Questions
What product was recalled? ▼
TCC-EZ, Total Contact Cast System, Model No. TCC2-4051. Recalled by Integra LifeSciences Corp.. Units affected: 250.
Why was this product recalled? ▼
A quarantined lot of the devices was released for sale. Devices from this lot may experience increased exothermic reaction causing higher levels of heat output which exceed the product specifications.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 2, 2018. Severity: Moderate. Recall number: Z-1487-2018.
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