Allen Medical Systems, Inc.
Bedford Heights, OH, US
Allen Medical Systems, Inc. appears in FDA device records in Bedford Heights, OH. FDA records list 5 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 14 recalls for this company.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Allen Medical Systems, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- The OR Group,Inc.recall
510(k) clearance history
FDA records hold 5 510(k) clearances for Allen Medical Systems, Inc. between 1993 and 1997. The busiest year on record is 1997, with 2. The most recent is 1997, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1993 | 1 |
| 1994 | 1 |
| 1996 | 1 |
| 1997 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K971988 | ALLEN, ULTRA AND SMART SOCKETS | FQO | Substantially Equivalent | |
| K964273 | DURA-BOARD ARMBOARD | GDC | Substantially Equivalent | |
| K960027 | HIGH VOLUME I.V. & IRRIGATION TOWER | FOX | Substantially Equivalent | |
| K944779 | CARBON LIGHTS HAND SURGERY TABLE | FWZ | Substantially Equivalent | |
| K921168 | ALLEN INFUSION PUMP MODEL 3000 AND IRRIGATION 2000 | KZD | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1262-2018 | F-T3SYSTEM, T3 (Trumpf Table Top) System The device is a surgical table accessory system used to allow prone positioning on OR table tops during spinal surgery. The system consists of a table top frame, arm supports, | The recalling firm has become aware that the rail section clamps used to attach the leg support of the device may fail during use, which could result in critical harm to the patient. | Class II | Terminated | |
| Z-0642-2018 | Radiolucent Surgery Spine Frame (F70801). Surgical platform used to position patients for lumbar spine procedures. | The base of the frame has the potential to crack when the patient is initially transferred to the Bow Frame. | Class II | Terminated | |
| Z-0641-2018 | Allen Medical Bow Frame Model A-70800. Surgical platform used to position patients for lumbar spine procedures. | The base of the frame has the potential to crack when the patient is initially transferred to the Bow Frame. | Class II | Terminated | |
| Z-1198-2017 | Arthrex Shoulder Suspension Tower; Catalog Number: AR-1650-01 Product Usage: The Arthrex Lateral Decubitus Shoulder Positioner is intended to allow for the controlled manipulation of the arm and shoulder joint during arthroscopic surgical procedures. | During use, there is a potential scenario which could allow the fastening screws attaching covers to come loose and potentially land in the sterile field causing a delay in surgery. | Class II | Terminated | |
| Z-0928-2017 | Arthex S3 Arm Sleeve Connector; Catalog Number AR-1650-02; manufactured and distributed between March and November 2016. | During use, the unit could separate un-expectantly. This failure would allow the patient's arm to fall out of suspension during a procedure, possibly causing moderate injury to the patient. This potential defect is not apparent to the user. | Class II | Terminated | |
| Z-0959-2013 | Allen Traction Boot, Modular, OT 1000 Traction Device Boot Assembly, Fracture Table Orthopedic Leg Holders, non-invasive medical devices designed to attach to orthopedic fracture tables to aid clinical staff in applying traction to the leg of a patient during surgical procedures. | Some units may have been assembled incorrectly which could result in the boot breaking free from the mounting base and allowing the patient's leg to fall. | Class II | Terminated | |
| Z-0655-2012 | Allen C-Flex Head Positioning System non-invasive medical device used to support a patient's head during spine surgery Catalog Numbers: A-70700 and A-70701-2 | C-Flex Polar Head Positioner may have an adjustment screw loosen and affect load capacity | Terminated | ||
| Z-1478-2008 | Allen Medical C-Flex, Polar Head Positioner Catalog Number: A-70700-A1 Product is a medical device used to maintain the position of an anesthetized patient during surgery. | Handle jamming in the open position, preventing the device from adequately supporting the head during spinal surgery. Possible delay in surgery, or injury. | Terminated | ||
| Z-0722-05 | Allen A-91000 Shoulder Positioner | Shoulder positioner may break near the rail that attaches to the operating table | Terminated | ||
| Z-1327-04 | Neuro Adapter 2 used with the Berchtold B-810 Surgical Table or Getinge USA Fortis Surgical Table Catalog No: MDTNA2 | Neuro adapter may fail to engage and adequately clamp to the surgical table, resulting in movement | Terminated | ||
| Z-0184-04 | Trumpf Universal Imaging Extension (OEM) Catalog NUmber: F-PMT-A2 | Imaging table with extension may fail if the table leg is incorrectly positioned and the load exceeds the maximum weight of 400 lb | Terminated | ||
| Z-0183-04 | Stryker Universal Imaging Extension (OEM) Catalog Number: R--934-TRIO-A1 | Imaging table with extension may fail if the table leg is incorrectly positioned and the load exceeds the maximum weight of 400 lb | Terminated | ||
| Z-0182-04 | Ronci Surgical Universal Imaging Extension used with the Ronci Pain Management Table System Catalog Number: R-934-25A | Imaging table with extension may fail if the table leg is incorrectly positioned and the load exceeds the maximum weight of 400 lb | Terminated | ||
| Z-0953-03 | Allen Medical Systems PAL Pro Stirrups Catalog Number: A-10051-A1 | Foot Stirrups may detach from mount when user is locking system | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain