Device recall: CUSTOM SPRYSTEP, custom made device dynamic ankle-foot orthosis (AFO) , Ref #s: 17C1000, 17C2000, 17C1010, 17C2010…
Class II FDA enforcement event 93299. Recall start date: . Status in the FDA record: Completed.
Reason for recall, in the words of FDA
Due to potential air pockets between layers of material, their is the potential for complete struct breakage of knee-ankle-foot orthosis.
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
Townsend Design started this device recall on 23 Sep 2023. The firm address in the FDA record is in Bakersfield, CA. FDA put the recall in Class II. FDA event 93299 has 3 product records. The first FDA enforcement report date is 17 Jan 2024. The record gives the status Completed.
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.
US: AL AR AZ CA CO CT DC DE FL GA IA ID IL IN KENT KS KY LA MA MD ME MI MN MO MS MT NC NE NH NJ NM NV NY OH OK OR PA QC SC SD TN TX UT VA VT WA WI WV WY, Puerto Rico, OUS: None OUS: Canada, New…
Recalling firm
Townsend Design, Bakersfield, CA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
3 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0670-2024 | CUSTOM SPRYSTEP, custom made device dynamic ankle-foot orthosis (AFO) , Ref #s: 17C1000, 17C2000, 17C1010, 17C2010, 17C1040, 17C2040 | 248 units | Class II | Completed | 17 Jan 2024 |
| Z-0671-2024 | SPRYSTEP VECTOR, Custom made device dynamic ankle-foot orthosis (AFO) , Reference numbers: 17V1030, 17V2030, 17V1031, 17V2031, 17V1032, 17V2032, 17V1033, 17V2033, 17V1035, 17V2035, 17V1036, 17V2036, 17V1037, 17V2037 | 898 units | Class II | Completed | 17 Jan 2024 |
| Z-0672-2024 | SPRYSTEP VECTOR KAFO, Custom made device dynamic ankle-foot orthosis (KAFO) non locking, REF #s: 17VKCUS and 17VKCUSX | 334 units | Class II | Completed | 17 Jan 2024 |
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 2023
- 917
- Share of these events in Class II
- 88%
- Product records in this event
- 3
- Events of the firm on the register
- 1
Official channels
- FDA enforcement report Z-0670-2024The 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 93299. https://recallregister.com/fda/ii/93299/. 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:
US: AL AR AZ CA CO CT DC DE FL GA IA ID IL IN KENT KS KY LA MA MD ME MI MN MO MS MT NC NE NH NJ NM NV NY OH OK OR PA QC SC SD TN TX UT VA VT WA WI WV WY, Puerto Rico, OUS: None OUS: Canada, New…
- What quantity of product is in FDA event 93299?
- The event has 3 product records. The first record gives this quantity:
248 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2023 have the same class?
- 88% of the 917 device events that started in 2023 are in Class II.