Medtronic Percutaneous Pin Adapter Recall for Potential Rotation
Medtronic is recalling 1,297 percutaneous pin adapters because they may rotate after surgical placement and fail to return to their original position.
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 medical device with a functional defect that could compromise surgical stability, fitting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medtronic Navigation, Inc. is recalling 1,297 Medtronic Adapter Percutaneous Pin units. These adapters are components of the StealthAir Frame Assembly and are distributed in various kits, including the Upgrade Set Percutaneous Pin and Medtronic Adapter Percutaneous Pin Kit. The affected lot numbers are 150114, 150505, 150506, 150904, 151005, 151007, 160201, 160224, 160419, 160617, 160707, 170216, 180110, and 180409.
The recall was initiated because, under certain circumstances, the percutaneous pin adapter may slightly rotate after surgical placement. This rotation may prevent the adapter from returning to its original position, even when the connections are tight and secure.
Distribution was nationwide, including government, military, and foreign distribution. Healthcare facilities and patients who have received these specific adapters should contact Medtronic Navigation, Inc. for further instructions on replacement or remediation.
The recalled product
- Product
- Medtronic Adapter Percutaneous Pin, REF 9734752 (GTIN 00643169529489) and REF 9734752-G02 (GTIN 00763000054915), contained in the following kits: Upgrade Set Percutaneous Pin, REF 9735502 (GTIN 00643169529533) and REF 9735502-G02 (GTIN 00763000208462); Medtronic Adapter Percuta
- Manufacturer
- Medtronic Navigation, Inc.
- Affected units
- 1,297
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 (13)
- Percutaneous pin adapter lot numbers: 150114
- 150505
- 150506
- 150904
- 151005
- 151007 160201
- 160224
- 160419
- 160617
- 160707
- 170216
- 180110
- and 180409.
Distribution
Distributed nationwide across the United States.
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