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Open, Classified

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

FDA Recall Z-1574-2023 · Posted 2023-05-10

Recalling FirmMedtronic Sofamor Danek USA Inc
Recall StatusOpen, Classified
Product CodeLXH
Date Initiated2021-11-19
Product Quantity4 units

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.

Firm Action

Medtronic issued an URGENT; Medical Device Removal notice on 11/19/2021. The notice explained the issue and the risk and requested the removal of the affected product from use pending return. It also directed the consignee to transfer the notice to other organizations which could be affected.

Root Cause

Under Investigation by firm

Distribution Pattern

US: IN, CT, NE

Official Source

View FDA Recall →

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

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