Device recall: Unity Total Knee System. Used for knee prosthesis in total knee replacement
Class II FDA enforcement event 91039. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
The internal packaging system for devices may have damage to the blisters potentially damaging the device or compromising the sterility of the packaging.
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
Corin Ltd started this device recall on 31 Oct 2022. The firm address in the FDA record is in Cirencester. FDA put the recall in Class II. FDA event 91039 has 1 product record. The first FDA enforcement report date is 30 Nov 2022. The record gives the status Terminated, with the termination date 12 Jan 2024.
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 in the US to New Jersy and Puerto Rico. International distribution to South Africa and France.
Recalling firm
Corin Ltd, Cirencester, N/A, United Kingdom.
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-0273-2023 | Unity Total Knee System. Used for knee prosthesis in total knee replacement | 4 devices | Class II | Terminated | 30 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
- 1Median of the firm: 2
- Events of the firm on the register
- 8
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 13 Oct 2023 | Unity CR Femur Right, Size 6, Model Number 112.001.32 Primary and revision total knee arthroplasty | Device | Class II | 2 |
| 8 Nov 2022 | Corin BIOLOX DELTA MOD HEAD,032mm, EX LONG +7mm, REF 104.3215 | Device | Class II | 2 |
| 22 Jul 2022 | Corin METAFIX HIP STEM, SIZE 3, STANDARD, 135 degrees, COLLARED HIP STEM, CEMENTLESS, Part Number 579.0103 | Device | Class II | 1 |
| 12 Jul 2022 | TaperFit Stem, Size 0, 38mm OFFSET, 12/14 Taper + 188.550 Centraliser, For Cemented Use, REF 588.3800. Orthopedic hip im | Device | Class II | 1 |
| 28 Jul 2021 | Corin TriFit TS, Size 8, Standard Tapered Stem, REF 694.0008, Sterile. | Device | Class II | 10 |
| 6 May 2021 | Corin TriIFit TS SIZE 2, STANDARD TAPERED STEM, CEMENTLESS, REF 694.0002. Hip prosthesis component. | Device | Class II | 2 |
| 25 Jan 2021 | Corin BIOLOX DELTA MOD HEAD 32mm EX LONG +7mm 12/14 TAPER. Corin Trinity Acetabular System with Extra Long Heads/Trinity | Device | Class II | 2 |
Official channels
- FDA enforcement report Z-0273-2023The 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 91039. https://recallregister.com/fda/ii/91039/. 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 in the US to New Jersy and Puerto Rico. International distribution to South Africa and France.
- What quantity of product is in FDA event 91039?
- The FDA record gives this quantity:
4 devices
- 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.