Device recall: Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis
Class II FDA enforcement event 91479. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
Device was shipped without having regulatory approval.
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
Stryker Leibinger GmbH & Co. KG started this device recall on 6 Dec 2022. The firm address in the FDA record is in Freiburg Im Breisgau. FDA put the recall in Class II. FDA event 91479 has 1 product record. The first FDA enforcement report date is 15 Mar 2023. The record gives the status Ongoing.
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.
Distribution of one unit only to a single customer in MA (USA)
Recalling firm
Stryker Leibinger GmbH & Co. KG, Freiburg Im Breisgau, Germany.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1234-2023 | Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis | 1 unit | Class II | Ongoing | 15 Mar 2023 |
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
- 1Median of the firm: 1
- Events of the firm on the register
- 7
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 4 Apr 2024 | 8000-021-002, Scopis ENT Software with TGS with Sofware Version: NOVA 3.6.0 RC16. Scopis is a next-generation solution f | Device | Class II | 1 |
| 29 Mar 2024 | Stryker 1,5/1,7MM DYNAMIC MESH- STD-MEDIUM-Intended for the reconstruction, stabilization and rigid fixation of the bony | Device | Class II | 1 |
| 29 Dec 2021 | MEDPOR Titan OFW - MTB - Right - 1.0mm, Catalog number 81032 | Device | Class II | 1 |
| 1 Apr 2021 | DirectInject consists of a sterile dual paste system which is calcium phosphate based. Upon injection through the Mixer- | Device | Class II | 1 |
| 22 Jun 2018 | QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01520S The Stryker QuickFlap Ster | Device | Class II | 18 |
| 3 Jan 2017 | QUINTUBE Monitor Pack (5 tubes/pk, 24 pk/case) (Non-Sterile) SPG Bulb Drain System, 4mm Flat w/Center Holes (Sterile) Ac | Device | Class II | 2 |
Official channels
- FDA enforcement report Z-1234-2023The 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 91479. https://recallregister.com/fda/ii/91479/. 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:
Distribution of one unit only to a single customer in MA (USA)
- What quantity of product is in FDA event 91479?
- The FDA record gives this quantity:
1 unit
- 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.