Distractor Rack, REF 5598007, which may be packaged in Modular Distractor Set, Loaner Kit Number SPS03139; for use in spinal surgery
Reported: May 17, 2023 Initiated: November 19, 2021 #Z-1574-2023
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.
Details
- Recalling Firm
- Medtronic Sofamor Danek USA Inc
- Units Affected
- 4 units
- Distribution
- US: IN, CT, NE
- Location
- Memphis, TN
Frequently Asked Questions
What product was recalled? ▼
Distractor Rack, REF 5598007, which may be packaged in Modular Distractor Set, Loaner Kit Number SPS03139; for use in spinal surgery. Recalled by Medtronic Sofamor Danek USA Inc. Units affected: 4 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 17, 2023. Severity: Moderate. Recall number: Z-1574-2023.
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