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Z-0058-2016 Class II Terminated

Recalled by Resource Optimization & Innovation Llc — Springfield, MO

FDA device recall Z-0058-2016 was initiated by Resource Optimization & Innovation Llc on Apr 22, 2015 and is designated Class II. Reason for recall: The kits contain an equipment glove component which may contain splits or holes compromising the sterility. The recall status is terminated (terminated Mar 28, 2017). Affected quantity: 125 kits.

Recall Details

Product Type: Devices
Report Date: Oct 14, 2015
Initiation Date: Apr 22, 2015
Termination Date: Mar 28, 2017
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 125 kits

Product Description

regard Item Number: 800550, Sterile, OR0639 - Hip Shoulder - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Reason for Recall

The kits contain an equipment glove component which may contain splits or holes compromising the sterility.

Distribution Pattern

Distribution was made to LA, MS, and TX.

Code Information

Lot numbers 16657, 18362, 18552, 19853, 22815, 23635, and 24103.

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-0058-2016
openFDA file date: Oct 23, 2026
Loaded by RegDataLab: Oct 25, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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