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Acumed LLC FDA Recalls
9 recalls on file across devices, 0 of them Class I and 7 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Acumed Hexalob Screw various sizes: REF Numbers: : 3070-27008 2.7mm x 8mm NL Hexalobe Screw; 3070-27009 2.7mm x 9mm NLClass IIMay 28, 2026Due to manufacturing error, hexalobe screws used with wrist |
| Acu-Loc and Acu-Loc 2 bone plates, screws and accessories for the following REF: 70-0045 Acu-Loc VDU Plate Standard, LefClass IIDec 19, 2023Distribution without Pre-Market Clearance |
| RibLoc U Plus 90 Instrument PRIMARY GUIDE ASSY, LOW PROFILE REF RBL2320 The RBL2320, Low Profile Primary Guide is an Class IINov 27, 2023Due to potential breakage during use. |
| Part Number/Part Description: 30-0033-S 30mm Acutrak¿ Fusion Device 6mm Nose AM-0025-S 25.0mm Acutrak¿ 4/5 BoClass IINov 29, 2022Distribution without Pre-Market Clearance |
| Dual-Trak Clavicle Screws Part Number/Part Description: 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 40-0136-S 3.0mmClass IINov 29, 2022Distribution without Pre-Market Clearance |
| Acutrak 2 Part Number/Part Description: 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 30-0021-S 25.0mm Acutrak 2¿ - 5.5 ScrewClass IINov 29, 2022Distribution without Pre-Market Clearance |
| AcuTwist Acutrak Compression Screws Part Number/Part Description: AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw Class IINov 29, 2022Distribution without Pre-Market Clearance |
| 4.0mm x 12mm Cannulated Screw, Short Thread; Part number 3005-40012Class IIMar 9, 2022Cannulated Screws 4.0mm x 10mm and 4.0mm x 12mm may not hav |
| 4.0mm x 10mm Cannulated Screw, Short Thread; Part number 3005-40010Class IIMar 9, 2022Cannulated Screws 4.0mm x 10mm and 4.0mm x 12mm may not hav |