Reported Feb 5, 2025 · Ongoing
Medtronic PIN, 100mm STERILE PERCUTANEOUS REF: 9733235 Medtronic PIN, 150MM, STERILE PERCUTANEOUS REF: 97733236 The…
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. · 200 Medtronic Dr · Lafayette, CO · 80026-3735
Is this the product you have?
- Medtronic PIN, 100mm
- STERILE PERCUTANEOUS REF
9733235 Medtronic PIN150MM
- STERILE PERCUTANEOUS REF97733236 The Sterile Percutaneous Reference Pin Set is intended to be used to place and remove a pin percutaneously into bony patient anatomy for rigid attachment of a patient reference during image-guided surgeries using a Medtronic computer-assisted surgery system
- Lot codes and dates
- Sterile Percutaneous Pin, 100mm
- Product Number9733235
- UDI-DI code00613994247872
- Serial/Lot Numbers
62 of 62 codes
202307114220230803272023080330202309135120230913532023091354202309135520230913562023100459202310046020231011392023101140202310147020231014722023101473202311036820231103702023110371202311082120231108232023110824202311148920231114902023111491202312000820231200092023120434202312083420231208352023121177202401033020240103322024011153202402101120240210142024021015202402101620240211002024021103202402136520240403272024040895202404089620240506862024050687202405068820240512212024051222202405122520240512262024060262202406047920240604802024060484202407040820240704092024070410202407041120240704142024070415
- GTIN code (Japan only)00643169105676
- Serial/Lot Numbers2023091351 2023100459 2023101140 2023101472 2023101473 Sterile Percutaneous Pin, 150mm
- Product Number9733236
- UDI-DI code613994247865
- Serial/Lot Numbers
20230711432023071144202309135720230913582023091359202309136020231011412023101142202310147120231103722023110373202311082220231114922023120010202312003920231200402023120041202312004220231204312023120432202312043320231208312023120832202312117820240103332024010334202401115420240111552024021012202402101320240211012024021102202402136420240213662024021367202404032520240403282024040897202404089820240506892024051224202406026320240604812024060482202406048320240704132024070416202407041720240805342024080535
- GTIN code (Japan only)643169105669
- Serial/Lot Numbers2023071143 2023071144 2023101142 2023110822 2023120010
- Amount recalled
- 67,370 pins
Where it was sold
Why it was recalled
Due to an increase in complaint that the percutaneous reference pin would not fit into the patient reference frame or percutaneous pin adapter.
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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