Device recall: Allen Advance Table, RSP-ADVANCE TABLE: a) REF A-71100-US, #107003, b) A-71101-EU, #107003. operating room table
Class II FDA enforcement event 90848. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly, and as a result, could result in a loss of holding and reduced mechanical integrity.
Class II, in the words of FDA
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
Baxter Healthcare Corporation started this device recall on 20 Sep 2022. The firm address in the FDA record is in Deerfield, IL. FDA put the recall in Class II. FDA event 90848 has 6 product records. The first FDA enforcement report date is 9 Nov 2022. The record gives the status Terminated, with the termination date 4 Aug 2026.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
MI, BA, WI, WA, TX, and Germany, Japan, South Korea, Sweden, South Africa
Recalling firm
Baxter Healthcare Corporation, Deerfield, IL.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
6 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0175-2023 | Allen Advance Table, RSP-ADVANCE TABLE: a) REF A-71100-US, #107003, b) A-71101-EU, #107003. operating room table | 2 units | Class II | Terminated | 9 Nov 2022 |
| Z-0176-2023 | C-Flex Polar Head Positnr-Device Only, SSP-NEUROSURGICAL HEADREST, REF A-70701, #103001, | 2 units | Class II | Terminated | 9 Nov 2022 |
| Z-0177-2023 | Allen Standard Starburst, Mayfield/Doro, STANDARD SPINE POSITIONERS CMPT, REF A-70710, #800103. Component to position and support the patients head in surgical procedures. | 2 units | Class II | Terminated | 9 Nov 2022 |
| Z-0178-2023 | Beach Chair Clamp, BEACH CHAIR SHLDER POSITIONER CMPT, REF A-90013, #800104. Component to position and support the patients head in surgical procedures. | 13 units | Class II | Terminated | 9 Nov 2022 |
| Z-0179-2023 | Allen Life Assist Beach Chair, BCSSP-BEACH CHAIR , REF A-91501, #104002. For use with orthopaedic procedures using the Fowlers or beach chair position. | 1 unit | Class II | Terminated | 9 Nov 2022 |
| Z-0180-2023 | Simple Clamp, US/EURO Rails, UPPER EXTREMITY DISTRACTION CMPT, REF F-40018, #800101. To position, support and/or distract the patients hand, wrist, forearm, arm, and shoulder in surgical procedures. | 1 unit | Class II | Terminated | 9 Nov 2022 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2022
- 839
- Share of these events in Class II
- 88%
- Product records in this event
- 6Median of the firm: 1
- Events of the firm on the register
- 193
Other events of the firm
Official channels
- FDA enforcement report Z-0175-2023The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 90848. https://recallregister.com/fda/ii/90848/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
MI, BA, WI, WA, TX, and Germany, Japan, South Korea, Sweden, South Africa
- What quantity of product is in FDA event 90848?
- The event has 6 product records. The first record gives this quantity:
2 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2022 have the same class?
- 88% of the 839 device events that started in 2022 are in Class II.