Device recall: Allen Medical Bow Frame Model A-70800. Surgical platform used to position patients for lumbar spine procedures.
Allen Medical Systems (Acton, MA) initiated this device recall on 6 Oct 2017; FDA lists 2 product records under event 79205, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 93% of the 1,091 device enforcement events initiated in 2017 carry the same class.
Status: Terminated, terminated 3 Apr 2019. Initiation: voluntary: firm initiated. Allen Medical Systems has 2 enforcement events on this register, with a median of 2 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Allen Medical Systems, Acton, MA.
Reason for recall
"The base of the frame has the potential to crack when the patient is initially transferred to the Bow Frame."
Distribution
"Worldwide distribution. US Nationwide, Australia, Bangladesh, Brazil, Canada, China, Denmark, France, Germany, Greece, Italy, Japan, Korea, Kuwait, Lebanon, Malaysia, Netherlands, Spain,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0641-2018 | Allen Medical Bow Frame Model A-70800. Surgical platform used to position patients for lumbar spine procedures. | 161 units total | Class II | Terminated | 28 Feb 2018 |
| Z-0642-2018 | Radiolucent Surgery Spine Frame (F70801). Surgical platform used to position patients for lumbar spine procedures. | 161 units total | Class II | Terminated | 28 Feb 2018 |
Context
Other enforcement events for Allen Medical Systems
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 21 Feb 2018 | F-T3SYSTEM, T3 (Trumpf Table Top) System The device is a surgical table accessory system used to allow prone positioning (79613) | Device | Class II | 1 |
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The base of the frame has the potential to crack when the patient is initially transferred to the Bow Frame."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide distribution. US Nationwide, Australia, Bangladesh, Brazil, Canada, China, Denmark, France, Germany, Greece, Italy, Japan, Korea, Kuwait, Lebanon, Malaysia, Netherlands, Spain,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 3 Apr 2019. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.