Reported Dec 25, 2019 · Terminated
Medtronic Adapter Percutaneous Pin, REF 9734752 (GTIN 00643169529489) and REF 9734752-G02 (GTIN 00763000054915),…
Medtronic Navigation, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Navigation, Inc. · 826 Coal Creek Cir · Louisville, CO · 80027-9710
Is this the product you have?
3 of 3 products
| Model / number | Barcodes | Product as published |
|---|---|---|
00763000208462 | 006431695294890076300005491500643169529533 | 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 ( ) |
00643169540521 | Medtronic Adapter Percutaneous Pin Kit, REF 9734752K ( ) | |
00643169641006 | and Medtronic Adapter Percutaneous Pin Kit, REF 9734752K ( ) (Japan). The percutaneous pin adapter is a component of the StealthAir Frame Assembly. |
- Lot codes and dates
- Percutaneous pin adapter lot numbers
150114150505150506150904151005151007 160201160224160419160617160707170216180110and 180409
- Percutaneous pin adapter lot numbers
- Amount recalled
- 1,297 percutaneous pin adapters
Where it was sold
- Nationwide
Why it was recalled
Under certain circumstances, the percutaneous pin adapter used with the StealthAir Frame Assembly may slightly rotate after surgical placement and not return to its original position, even when connections are tight and secure.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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