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Distractor Rack, REF 5598007, which may be packaged in Modular Distractor Set, Loaner Kit Number ...

FDA Recall #Z-1574-2023 — Class II — November 19, 2021

Recall #Z-1574-2023 Date: November 19, 2021 Classification: Class II Status: Ongoing

Product Description

Distractor Rack, REF 5598007, which may be packaged in Modular Distractor Set, Loaner Kit Number SPS03139; for use in spinal surgery

Reason for Recall

Two lots of the 5598007 Distractor Rack which were not manufactured to specification. The crest width of the gear is too wide and may cause difficulty or the inability to operate the Distractor.

Recalling Firm

Medtronic Sofamor Danek USA Inc — Memphis, TN

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

4 units

Distribution

US: IN, CT, NE

Code Information

UDI/DI (GTIN) 00763000401535, Lot Numbers EM21D006, EM21D007; Loaner Kit Lot numbers: 0072, 0073, 0077, 0098, 0103

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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