Medtronic Spinal Distractor Rack Recalled for Manufacturing Defect
Medtronic is recalling Distractor Rack devices used in spinal surgery due to manufacturing defects that may prevent proper device operation. Two lot numbers are affected and were distributed to facilities in Indiana, Connecticut, and Nebraska.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of a surgical device with a manufacturing defect that prevents normal operation. This is a risk-of-harm product where no injuries or illnesses have been reported, making it a theoretical hazard that warrants the maximum score of 3.
Plain-English summary
Medtronic Sofamor Danek USA Inc is recalling Distractor Rack devices (Reference Number 5598007) used in spinal surgery. These devices may be packaged in Modular Distractor Sets or included in Loaner Kits.
Two manufacturing lots of this device contain a defect: the crest width of the gear is too wide. This defect may cause difficulty or prevent proper operation of the Distractor during spinal surgery.
The recall affects 4 units that were distributed to healthcare facilities in Indiana, Connecticut, and Nebraska. The affected lot numbers are EM21D006 and EM21D007 for the distractor racks, and lot numbers 0072, 0073, 0077, 0098, and 0103 for the loaner kits.
The recalled product
- Product
- Distractor Rack, REF 5598007, which may be packaged in Modular Distractor Set, Loaner Kit Number SPS03139; for use in spinal surgery
- Manufacturer
- Medtronic Sofamor Danek USA Inc
- Affected units
- 4
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- UDI/DI (GTIN) 00763000401535
- Lot Numbers EM21D006
- EM21D007
- Loaner Kit Lot numbers: 0072
- 0073
- 0077
- 0098
- 0103
Distribution
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