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Devices
Device Recall Stylus Brand Angled Knives
Model / Serial
Model No. Lot # Exp.date 52-2661 M309600 5/2008 52-2662 M309610 8/2008 52-2661 M309620 8/2008 52-2661 M309630 8/2008 52-2661 M264510 3/2008 52-2761 M436360 12/2008 52-2761 M309720 9/2008 52-2761 M309730 9/2008 52-2761 M365020 10/2008 52-2761 M365030 11/2008 52-2861 M309770 5/2008 52-2861 M309780 7/2008 52-2861 M430490 12/2008 52-2861 M437160 1/2009 52-2861 M439540 1/2009 52-2861 M309790 8/2008 52-2861 M309810 9/2008 52-2961 M376790 8/2008 52-2961 M309860 6/2008 52-2961 M309870 7/2008 52-2961 M416990 10/2008 52-3261 M440600 2/2009 52-3261 M262580 3/2008 52-3261 M309940 7/2008 52-3261 M309960 8/2008 52-3261 M309970 8/2008 52-3561 M311070 4/2008 52-2662 M445610 2/2009 52-3262 M280120 3/2008
Product Classification
Ophthalmic Devices
Device Class
1
Implanted device?
No
Distribution
Distribution was nationwide and internationally
Product Description
Stylus Brand Angled Knife - 52-2661, Slit Knife, bevel up, angled full handled, 2.65mm || 52-2761, Slit Knife, bevel up, angled, full handled, 2.75mm || 52-2861, Slit Knife, bevel up, angled, full handled, 2.85mm || 52-2961, Slit Knife, bevel up, angled, full handled, 3.0mm || 52-3261, Slit Knife, bevel up, angled, full handled, 3.2mm || 52-3561, Slit Knife, bevel up, angled, full handled, 3.5mm || 52-2662, Slit Knife, bevel up, angled, blade and tip, 3.2mm || 52-3262, Slit Knife, bevel up, angled, blade and tip, 3.2mm
Manufacturer
Surgical Specialties Puerto Rico, Inc.
1 Event
Recall of Device Recall Stylus Brand Angled Knives
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Manufacturer
Surgical Specialties Puerto Rico, Inc.
Manufacturer Address
Surgical Specialties Puerto Rico, Inc., Road 115 Km.12.9, Rincon PR 00677
Source
USFDA
5 devices with a similar name
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Device Recall Stylus Brand Angled Knives
Model / Serial
Model No. Lot # Exp. date 52-2835 M454660 2/2009 52-2835 M317210 7/2008
Product Classification
Ophthalmic Devices
Device Class
1
Implanted device?
No
Distribution
Distribution was nationwide and internationally
Product Description
Stylus Angled Knife - 52-2835 Clear Corneal Knife, double bevel, parallel sides, angled, full handle, 2.85mm
Manufacturer
Surgical Specialties Puerto Rico, Inc.
Device Recall Stylus Brand Angled Knives
Model / Serial
Model No. Lot # Exp. date 56-5361 M262510 5/2008 56-5361 M309090 6/2008 56-5361 M309150 11/2008 56-5361 M439510 1/2009 56-5161 M317030 6/2008
Product Classification
Ophthalmic Devices
Device Class
1
Implanted device?
No
Distribution
Distribution was nationwide and internationally
Product Description
Stylus Angled Knife - 56-5361, Pilot Tip Knife, bevel up, angled, full handled, 3.2mm and 56-5161, Pilot Tip Knife, bevel up, angled, full handled, 5.2mm
Manufacturer
Surgical Specialties Puerto Rico, Inc.
Device Recall Stylus Brand Angled Knives
Model / Serial
Model No. Lot # exp. date 52-2931 M310120 7/2008 52-2231 M310180 8/2008 52-3231 M310190 6/2008
Product Classification
Ophthalmic Devices
Device Class
1
Implanted device?
No
Distribution
Distribution was nationwide and internationally
Product Description
Stylus Brand Angled Knife ¿ 52-2931, Slit Knife, double bevel, angled, full handle, 3.0mm || 52-3231, Slit Knife, double bevel, angled, full handle, 3.2mm
Manufacturer
Surgical Specialties Puerto Rico, Inc.
Device Recall Stylus Brand Angled Knives
Model / Serial
Model No. Lot # Exp. Date 54-1010 M316220 9/2008 54-1010 M316160 7/2008 54-1010 M316180 7/2008 54-1031 M365220 10/2008
Product Classification
Ophthalmic Devices
Device Class
1
Implanted device?
No
Distribution
Distribution was nationwide and internationally
Product Description
Stylus Brand Angled Knife - 54-1010, Sharptome Crescent Knife, bevel up, angled, full handled. || 54-1031, Sharptome Crescent Knife, double bevel, angled, full handled
Manufacturer
Surgical Specialties Puerto Rico, Inc.
Device Recall Stylus Brand Angled Knives
Model / Serial
Model No. Lot # Exp. date 52-2912 M314590 5/2008 52-3212 M359090 7/2008
Product Classification
Ophthalmic Devices
Device Class
1
Implanted device?
No
Distribution
Distribution was nationwide and internationally
Product Description
Stylus Brand Angled Knives - 52-2912, Slit Knife, parallel sides, bevel up, angled, full handle, 3.0mm || 52-3212, Slit Knife, parallel sides, bevel up, angled, full handle, 3.2mm
Manufacturer
Surgical Specialties Puerto Rico, Inc.
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