Device recall: SWANSON GREAT TOE, TITANIUM SZ 4, Part Number 4833104
Class II FDA enforcement event 84180. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
The firm discovered a lack of adequate documentation confirming sterility on certain products.
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
Wright Medical Technology, Inc. started this device recall on 8 Nov 2016. The firm address in the FDA record is in Arlington, TN. FDA put the recall in Class II. FDA event 84180 has 12 product records. The first FDA enforcement report date is 4 Dec 2019. The record gives the status Terminated, with the termination date 3 Nov 2020.
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 and Norway, Italy, Germany, France, South Africa, UK, Taiwan, Austria, Japan, Turkey, Denmark, Canada, Switzerland, Belgium, The Netherlands, Spain
Recalling firm
Wright Medical Technology, Inc., Arlington, TN.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
12 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0562-2020 | SWANSON GREAT TOE, TITANIUM SZ 4, Part Number 4833104 | 30 units | Class II | Terminated | 4 Dec 2019 |
| Z-0563-2020 | ORTHOLOC 3DI PLT SYS STERILE, LOCKING SCREW, 3.5 x 38mm Sterile, Part Number 58S03538 | 40 units | Class II | Terminated | 4 Dec 2019 |
| Z-0564-2020 | PRO-STIM 10cc INJECTABLE, Part Number 86SR0410 | 19 units | Class II | Terminated | 4 Dec 2019 |
| Z-0565-2020 | INBONE STEM, TIBIAL, TOP, Part Number 200011901 | 65 units | Class II | Terminated | 4 Dec 2019 |
| Z-0566-2020 | VALOR SCREW 5.0MM X 45MM LEN, Part Number 4151150045 | 54 units | Class II | Terminated | 4 Dec 2019 |
| Z-0567-2020 | Dart Fire HEADED SCREW 4.0X 32MM, Part Number D1S40032S | 77 units | Class II | Terminated | 4 Dec 2019 |
| Z-0568-2020 | Darco STERILE HEADED DRILL BIT 4.4MM , Part Number 777S06514 | 66 units | Class II | Terminated | 4 Dec 2019 |
| Z-0569-2020 | EVANS OPENING WEDGE PLATE 10MM, Part Number 58S30010 | 30 units | Class II | Terminated | 4 Dec 2019 |
| Z-0570-2020 | SWANSON FINGER JOINT #1, Part Number 4700001 | 20 units | Class II | Terminated | 4 Dec 2019 |
| Z-0571-2020 | SWANSON FINGER JOINT #2, Part Number 4700002 | 18 units | Class II | Terminated | 4 Dec 2019 |
| Z-0572-2020 | SWANSON TRAPEZIUM IMPLANT, Part Number 4520002 | 20 units | Class II | Terminated | 4 Dec 2019 |
| Z-0573-2020 | CPS CALCANEAL PLATE SML 54MM, Part Number DCS2805001 | 42 units | Class II | Terminated | 4 Dec 2019 |
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 2016
- 1,232
- Share of these events in Class II
- 91%
- Product records in this event
- 12Median of the firm: 2
- Events of the firm on the register
- 26
Other events of the firm
Official channels
- FDA enforcement report Z-0562-2020The 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.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 84180. https://recallregister.com/fda/ii/84180/. 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 and Norway, Italy, Germany, France, South Africa, UK, Taiwan, Austria, Japan, Turkey, Denmark, Canada, Switzerland, Belgium, The Netherlands, Spain
- What quantity of product is in FDA event 84180?
- The event has 12 product records. The first record gives this quantity:
30 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2016 have the same class?
- 91% of the 1,232 device events that started in 2016 are in Class II.