Reported Apr 4, 2018 · Terminated
1. InterPulse Handpiece with coaxial bone cleaning tip, Product Number: 0210-110-100, UDI: (01)4546540861641; 2.…
Stryker Instruments Div. of Stryker Corporation
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: Stryker Instruments Div. of Stryker Corporation · 4100 E Milham Ave · Portage, MI · 49002-9704
Is this the product you have?
4 of 4 products
| Model / number | Barcodes | Product as published |
|---|---|---|
0210-110-100 | 4546540861641 | InterPulse Handpiece with coaxial bone cleaning tip, , UDI: (01)4546540861641 |
0210-114-100 | 4546540861764 | InterPulse Handpiece with Coaxial High Flow Tip, , UDI: (01)4546540861764 |
0210-118-200 | 4546540861818 | InterPulse Handpiece with Retractable Coaxial Fan Spray Tip, , UDI: (01)4546540861818 |
0210-218-000 | 4546540144300 | InterPulse Irrigation Only Handpiece with Fan Spray Tip, , UDI: (01)4546540144300 for orthopedic use. |
- Lot codes and dates
3 of 3 products
Products covered by this recall # Barcodes Product as published 1 Lot Numbers: 17278012, 17280012, 17282012, 17283012, 17285012, 17289012, 17292012; 3. 2 Lot Number: 17279012; 4. 3 4546540861641454654086176445465408618184546540144300Lot Number: 17284012 UDI: (01)4546540861641; (01)4546540861764; (01)4546540861818; (01)4546540144300 - Amount recalled
- 5988
This recall covers 14 products
The agency filed one notice per product. You are reading one of them; the other 13 are below.
1 more are in the archive.
Where it was sold
Why it was recalled
Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
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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