Recall Z-2600-2018— Encore Medical, Lp
Class II · Terminated
Class II FDA medical device recall by Encore Medical, Lp, initiated 2018-06-26, terminated 2023-08-22. FDA's recall record names no specific 510(k) clearance for this event. Product: Instrument trays used to store AltiVate Small Shell Trials (FA S ALTIVATE RSP HUM TRLS SM). Metal container with lid used to organize and transport instrumentation to be used in orthopedic surgery. Inner trays also used to facilitate cleaning and sterilization of the instrumentation by end users.. Reason: A black, aluminum oxide coating may appear on the tray after cleaning. The black, aluminum oxide coating is not biocompatible..
- Recalling firm
- Encore Medical, Lp
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-06-26
- Terminated
- 2023-08-22
- Firm location
- Austin, TX, United States
Product description
Instrument trays used to store AltiVate Small Shell Trials (FA S ALTIVATE RSP HUM TRLS SM). Metal container with lid used to organize and transport instrumentation to be used in orthopedic surgery. Inner trays also used to facilitate cleaning and sterilization of the instrumentation by end users.
Reason for recall
A black, aluminum oxide coating may appear on the tray after cleaning. The black, aluminum oxide coating is not biocompatible.
Data sourced from openFDA. This site is unofficial and independent of the FDA.