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Credits
Manufacturers
Surgical Specialties Puerto Rico, Inc.
Manufacturer Address
Surgical Specialties Puerto Rico, Inc., Road 115 Km.12.9, Rincon PR 00677
Source
USFDA
7 Events
Recall of Device Recall Stylus Brand Slit Knife
Recall of Device Recall Stylus Brand Angled Knives
Recall of Device Recall Stylus Brand Angled Knives
Recall of Device Recall Stylus Brand Angled Knives
Recall of Device Recall Stylus Brand Angled Knives
Recall of Device Recall Stylus Brand Angled Knives
Recall of Device Recall Stylus Brand Angled Knives
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7 devices in the database
Device Recall Stylus Brand Slit Knife
Model / Serial
Model number: 52-2761 Lot/Serial # Exp. Date M262530 2/2008 M262540 3/2008 M262550 3/2008
Product Classification
Ophthalmic Devices
Device Class
1
Implanted device?
No
Distribution
Nationwide and worldwide. Distribution was to two accounts in the USA and four (4) foreign accounts.
Product Description
2.75 mm Slit Knife, Angled, Bevel Up. Labeled '' Stylus *** 2.75 mm Slit Knife Angled, Bevel, Up***One Unit STERILE R Disposable***Surgical Specialties Corporation***Reading, PA 19606***''
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
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
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
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
2 more
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