fda
12 records
FDA Recall: Acumed LLC — Class II
20240103
Due to potential breakage during use. | Product: RibLoc U Plus 90 Instrument PRIMARY GUIDE ASSY, LOW PROFILE REF RBL2320 The RBL2320, Low Profile
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FDA Device Recall: Acu-Loc and Acu-Loc 2 bone plates, screws and accessories for the following REF:
2024-03-06
Class II — Distribution without Pre-Market Clearance
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FDA Device Recall: RibLoc U Plus 90 Instrument PRIMARY GUIDE ASSY, LOW PROFILE REF RBL2320 The R
2024-01-03
Class II — Due to potential breakage during use.
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FDA Device Recall: Acutrak 2 Part Number/Part Description: 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw
2023-01-04
Class II — Distribution without Pre-Market Clearance
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FDA Device Recall: Dual-Trak Clavicle Screws Part Number/Part Description: 40-0136 3.0mm x 80mm D
2023-01-04
Class II — Distribution without Pre-Market Clearance
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FDA Device Recall: 4.0mm x 10mm Cannulated Screw, Short Thread; Part number 3005-40010
2022-04-27
Class II — Cannulated Screws 4.0mm x 10mm and 4.0mm x 12mm may not have sufficient axial pullout strength for the indicated use. Remote possibility of resulting in a mal or nonunion of the bone fragm...
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FDA Recall: Acumed LLC — Class II
20170607
The firm initiates a voluntary removal and discontinue marketing of Slide-Loc Anatomic Radial Head System based on its performance in the market. The | Product: The Acumed Slide-Loc Anatomic Radial H...
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FDA Recall: Acumed LLC — Class II
20170118
OPT Croutons, part number 65-0210-S, is recalled due to the result of inadequate documentation of the sterilization dose used in production. Product s | Product: OPT Croutons is a synthetic bone subst...
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FDA Device Recall: The Acumed Slide-Loc Anatomic Radial Head System is intended for use by surgeons
2017-06-07
Class II — The firm initiates a voluntary removal and discontinue marketing of Slide-Loc Anatomic Radial Head System based on its performance in the market. The firm received product complaints regar...
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FDA Device Recall: 6-hole Pubic Symphysis plate (PN 70-0451). The pelvic bone plates for the pelvi
2017-02-22
Class II — The 6-hole Pubic Symphysis plate (PN 70-0451) is specified to be made of Commercially Pure Titanium (ASTM F67 - CP Grade 4). However, batch 383813 was manufactured out of Titanium Alloy (Ti...
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FDA Device Recall: OPT Croutons is a synthetic bone substitute designed for the repair of bony defe
2017-01-18
Class II — OPT Croutons, part number 65-0210-S, is recalled due to the result of inadequate documentation of the sterilization dose used in production. Product sterilized at the site did not receive t...
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FDA Device Recall: The Osteo-Clage System consists of stainless steel cable/sleeves and compression
2014-05-07
Class II — Manufacturing of these devices with a grade of stainless steel that is not within specifications.
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nppes
1 records
ny_corps
1 records
NY Corp: ACUMED LLC
2003-07-03
FOREIGN LIMITED LIABILITY COMPANY | County: Albany | Jurisdiction: Delaware
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OSHA
1 records
OSHA Inspection (Complaint) - Acumed Llc
2010-06-09
OSHA inspection at Acumed Llc, HILLSBORO, OR. NAICS: 339112. SIC: 3841
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