Medtronic Recalls T8 Removal Heads Due to Incorrect Hardness Specification
Medtronic is recalling nine T8 Removal Heads used in spinal surgery due to incorrect hardness specifications that could cause the tool to fail during implant removal.
What this means for you
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: The recall involves a risk-of-harm medical device where injury (tissue damage) is a potential consequence, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Medtronic Sofamor Danek USA Inc is recalling nine units of the T8 Removal Head (Ref 8910641). The product is a non-sterile surgical instrument used with the Spire and Spire Z Spinal System to remove implants during surgery.
The recall was initiated because one lot of the T8 Removal Heads had an incorrect hardness specification. This defect could result in the removal head failing during the removal of the CD Horizon Spire and Spire Z Spinal System implant. If the tool fails, there is a potential for tissue damage to occur and/or minor surgical delay to remove the remaining fragments of the tip.
The affected units were distributed nationwide in the United States, specifically in the states of Georgia, Alaska, Washington, and California. The source text does not specify instructions for consumers or healthcare providers regarding the return or disposal of the recalled items.
The recalled product
- Product
- T8 REMOVAL HEAD, REF 8910641, QTY: 1 EA, Product Usage: The non-sterile T8 Removal Diriver is used with the Spire and Spire Z Spinal System in conjunction with the set screwdriver to remove the implant during removal surgery. The set screw driver is attached to the end of th
- Manufacturer
- Medtronic Sofamor Danek USA Inc
- Affected units
- 9
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 (1)
- RS12K008
Distribution
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