Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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.

FDA Recall Z-2600-2018 · Posted None

Recalling FirmEncore Medical, Lp
Recall StatusTerminated
Product CodeLRO
Date Initiated2018-06-26
Date Terminated2023-08-22
Product Quantity30 units

Reason for Recall

A black, aluminum oxide coating may appear on the tray after cleaning. The black, aluminum oxide coating is not biocompatible.

Firm Action

The firm, DJO LLC, sent an "URGENT FIELD SAFETY NOTICE" letter dated 6/26/2018 to its direct accounts by email on 06/26/2018. The letter described the product, problem and actions to be taken. The customers were instructed to return product; contact Customer Service as soon as possible to request an RMA for return and exchange of the full instrument set; and to coordinate the exchange of products with Customer Service. If you do not have these instrument sets or the number of sets identified above, you are required to complete the attached form and email it to [email protected]. ALL ACTIVITIES OUTLINED ABOVE SHOULD BE COMPLETED BY JULY 30, 2018. If you have any questions, please call (512) 834-6255 or by email to [email protected].

Root Cause

Process control

Distribution Pattern

US Distribution to states of; AZ, CA, CO, FL, IN, NJ, NY, NV, MI, MN, MO, OH, RI, SC, TN, TX, UT and WA and country of; Japan.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑