Atlas FDA

Acumed LLC

47 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Acumed Hexalob Screw various sizes: REF Numbers: : 3070-27008 2.7mm x 8mm NL Hexalobe Scre recall (Z-2532-2026)Acumed LLC2026-06-23
Acu-Loc and Acu-Loc 2 bone plates, screws and accessories for the following REF: 70-0045 A recall (Z-1218-2024)Acumed LLC2024-02-29
RibLoc U Plus 90 Instrument PRIMARY GUIDE ASSY, LOW PROFILE REF RBL2320 The RBL2320, Low P recall (Z-0618-2024)Acumed LLC2023-12-26
Part Number/Part Description: 30-0033-S 30mm Acutrak Fusion Device 6mm Nose AM-0025-S 25.0 recall (Z-0767-2023)Acumed LLC2022-12-23
Acutrak 2 Part Number/Part Description: 30-0021 25.0mm Acutrak 2 - 5.5 Screw 30-0021-S 25. recall (Z-0768-2023)Acumed LLC2022-12-23
AcuTwist Acutrak Compression Screws Part Number/Part Description: AI-0010-S 10mm AcuTwist recall (Z-0769-2023)Acumed LLC2022-12-23
Dual-Trak Clavicle Screws Part Number/Part Description: 40-0136 3.0mm x 80mm Dual-Trak Cla recall (Z-0770-2023)Acumed LLC2022-12-23
.045 X 6 ST Guide Wire, Part number 45-0029-S, Sterile 10 pack of WS-1106ST and has a 6 in recall (Z-1483-2017)Acumed LLC2017-03-16
6-hole Pubic Symphysis plate (PN 70-0451). The pelvic bone plates for the pelvic ring are recall (Z-1199-2017)Acumed LLC2017-02-14
The Osteo-Clage System consists of stainless steel cable/sleeves and compression plates. . recall (Z-1515-2014)Acumed LLC2014-04-25
The Acumed Tension Band Pin is a fixation pin which is .0625" in diameter and is available recall (Z-1516-2014)Acumed LLC2014-04-25
The Polarus Plus Humeral Rod (part number HR-0824-S) is intended as an intramedullary fixa recall (Z-1357-2012)Acumed LLC2012-04-02
Ulnar Shorting Saw Blade is labeled in part: "Congruent Bone Plates, SIZE Ulnar Shortening recall (Z-1807-2010)Acumed LLC2010-06-16
Polarus(R) Humeral Fixation System, size: 3.5mm x 25.0mm Cortical Screw, QTY 1, Ref: HCO32 recall (Z-1602-2010)Acumed LLC2010-05-14
Intramedullary Fixation Rod, common name Fibula Rod, labeled IM Rod System Manufactured or recall (Z-1552-2010)Acumed LLC2010-05-10
Stableloc (TM) Wrist External Fixation System, Quantity 1. Packaged labeled, "Stableloc Wr recall (Z-1154-2010)Acumed LLC2010-03-16
Biotrak PLLA Pin, Resorbable Fixation System, Biotrak 20 mm Pin; sterile pin packaged in s recall (Z-0073-2010)Acumed LLC2009-10-23
Modular Shoulder Body Assembly, Left (SH-1540L-S) and Modular Shoulder Body Assembly, Righ recall (Z-0447-2009)Acumed LLC2008-12-11
5 Hole Locking 1st Tarsometatarsal Plate. Product labeled in part, "ACUMED 5885 NW Corneli recall (Z-2108-2008)Acumed LLC2008-09-20
4 Hole Locking 1st Tarsometatarsal Plate. Product labeled in part, "ACUMED 5885 NW Corneli recall (Z-2109-2008)Acumed LLC2008-09-20
4 Hole Locking 2nd and 3rd Tarsometatarsal Plate. Product labeled in part, "ACUMED 5885 NW recall (Z-2110-2008)Acumed LLC2008-09-20
Left Locking Proximal Metatarsal Wedge Plate. Product labeled in part, "ACUMED 5885 NW Cor recall (Z-2111-2008)Acumed LLC2008-09-20
Right Locking Proximal Metatarsal Wedge Plate. Product labeled in part, "ACUMED 5885 NW Co recall (Z-2112-2008)Acumed LLC2008-09-20
Left Locking Dorsal 1st MTP Fusion Plate. Product labeled in part, "ACUMED 5885 NW Corneli recall (Z-2113-2008)Acumed LLC2008-09-20
Left Locking 1st MTP Revision Fusion Plate. Product labeled in part, "ACUMED 5885 NW Corne recall (Z-2114-2008)Acumed LLC2008-09-20
Right Locking 1st MTP Revision Fusion Plate. Product labeled in part, "ACUMED 5885 NW Corn recall (Z-2115-2008)Acumed LLC2008-09-20
Left Locking 2st MTP/MPJ Combo Fusion Plate. Product labeled in part, "ACUMED 5885 NW Corn recall (Z-2116-2008)Acumed LLC2008-09-20
Right Locking 1st MTP/MPJ Combo Fusion Plate. Product labeled in part, "ACUMED 5885 NW Cor recall (Z-2117-2008)Acumed LLC2008-09-20
6mm Bone Graft Drill. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsbo recall (Z-2118-2008)Acumed LLC2008-09-20
10mm Bone Graft Drill. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsb recall (Z-2119-2008)Acumed LLC2008-09-20
Locking Clavicle Plate, 10 Holes Large Left. Product labeled in part, "ACUMED 5885 NW Corn recall (Z-2120-2008)Acumed LLC2008-09-20
Locking Clavicle Plate, 10 Holes Large Right. Product labeled in part, "ACUMED 5885 NW Cor recall (Z-2121-2008)Acumed LLC2008-09-20
Locking Clavicle Plate, 6 Holes Small Left. Product labeled in part, "ACUMED 5885 NW Corne recall (Z-2122-2008)Acumed LLC2008-09-20
Locking Clavicle Plate, 6 Holes Small Right. Product labeled in part, "ACUMED 5885 NW Corn recall (Z-2123-2008)Acumed LLC2008-09-20
Locking Clavicle Plate, 8 Holes, J-Plate Left. Product labeled in part, "ACUMED 5885 NW Co recall (Z-2124-2008)Acumed LLC2008-09-20
Locking Clavicle Plate, 8 Holes, J-Plate Right. Product labeled in part, "ACUMED 5885 NW C recall (Z-2125-2008)Acumed LLC2008-09-20
Locking Clavicle Plate, 8 Holes Large Left. Product labeled in part, "ACUMED 5885 NW Corne recall (Z-2126-2008)Acumed LLC2008-09-20
Locking Clavicle Plate, 8 Holes Large Right. Product labeled in part, "ACUMED 5885 NW Corn recall (Z-2127-2008)Acumed LLC2008-09-20
Locking Clavicle Plate, 8 Holes Medium Left. Product labeled in part, "ACUMED 5885 NW Corn recall (Z-2128-2008)Acumed LLC2008-09-20
Locking Clavicle Plate, 8 Holes Medium Right. Product labeled in part, "ACUMED 5885 NW Cor recall (Z-2129-2008)Acumed LLC2008-09-20
Locking Clavicle Plate, 8 Holes Small Right. Product labeled in part, "ACUMED 5885 NW Corn recall (Z-2130-2008)Acumed LLC2008-09-20
Locking Clavicle Plate, 9 Holes, J-Plate Left. Product labeled in part, "ACUMED 5885 NW Co recall (Z-2131-2008)Acumed LLC2008-09-20
Locking Clavicle Plate, 9 Holes, J-Plate Right. Product labeled in part, "ACUMED 5885 NW C recall (Z-2132-2008)Acumed LLC2008-09-20
Smooth or threaded metallic bone fixation fastener. 3.5mm x 14.0 mm Locking Cortical Screw recall (Z-2135-2008)Acumed LLC2008-09-11
Acu-Loc Distal Radius Plate, Standard, Left. Product labeled in part, " Acu-Loc Distal Rad recall (Z-2153-2008)Acumed LLC2008-08-28
3.5mm X 32.5mm Cortical Screw used with the Polarus Humeral Fixation System,. Product labe recall (Z-2155-2008)Acumed LLC2008-08-28
Osteo-Clage Cable System Package Assembly (01-0001-S). Product labeled in part, "2.0mm x 8 recall (Z-2140-2008)Acumed LLC2008-08-22

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Every clearance here is in the API, with alerts when new ones post.