Device recall: Corin TriFit TS, Size 8, Standard Tapered Stem, REF 694.0008, Sterile.
Class II FDA enforcement event 88589. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices.
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 28 Jul 2021. The firm address in the FDA record is in Cirencester. FDA put the recall in Class II. FDA event 88589 has 10 product records. The first FDA enforcement report date is 6 Oct 2021. The record gives the status Terminated, with the termination date 12 Jun 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.
US Nationwide distribution in the states of AZ, CA, FL, IL, OK, PA, TX, UT, and WI.
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
10 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2603-2021 | Corin TriFit TS, Size 8, Standard Tapered Stem, REF 694.0008, Sterile. | 5 | Class II | Terminated | 6 Oct 2021 |
| Z-2604-2021 | Corin Trinity Screw, diameter 6.5mm 35mm Length, Cancellous Bone Screw, REF 321.035, Sterile; and Corin Trinity Screw, diameter 6.5mm 50mm Length, Cancellous Bone Screw, REF 321.050, Sterile, both are components of the Trinity Acetabular System. | 6 units | Class II | Terminated | 6 Oct 2021 |
| Z-2605-2021 | Corin Trinity-i, diameter 50mm Taper Size 3, Non-Occluded Ti Plasma Shell, REF 320.03.350, Sterile, a component of the Trinity Acetabular System. | 2 units | Class II | Terminated | 6 Oct 2021 |
| Z-2606-2021 | Corin Trinity Liner ECIMA, diameter 40mm Neutral Offset, Taper Size 4, REF 322.04.640, Sterile; and Corin Trinity Liner ECIMA, diameter 36mm Neutral 4mm EPW, Taper Size 4 (Elevated Wall), REF 322.04.936, Sterile; both are components of the Trinity Acetabular System. | 5 units | Class II | Terminated | 6 Oct 2021 |
| Z-2607-2021 | Corin BIOLOX Delta Mod Head, diameter 28mm Medium 0mm, 12/14 Taper, REF 104.2805, Sterile, a component of the Trinity Acetabular System. | 4 | Class II | Terminated | 6 Oct 2021 |
| Z-2608-2021 | Corin Trinity Dual Mobility, Size 4, Dual Mobility CoCr Liner, REF 321.04.540, Sterile, and Corin Dual Mobility, Size 4 42 insert/28 head, REF 325.04.042, Sterile; both are components of the Trinity Dual Mobility System. | 2 | Class II | Terminated | 6 Oct 2021 |
| Z-2609-2021 | Corin MetaFix Hip Stem, Size 1, Short Neck, 135 degrees, Collared Hip Stem, REF 579.0201, Sterile. | 2 units | Class II | Terminated | 6 Oct 2021 |
| Z-2610-2021 | Corin Unity Knee Augments, Size 5, 6 & 7 / 10mm Thick, Femoral Posterior Augment, REF 1122370, Sterile, a component of the Unity Total Knee System. | 1 unit | Class II | Terminated | 6 Oct 2021 |
| Z-2611-2021 | Corin Unity Knee CS Insert, Size 5 / 9.0mm, Fixed Condylar Stabilised - UHMWPE, REF 1125182, Sterile, and Corin Unity Knee CS Insert, Size 8 / 10.0mm, Fixed Condylar Stabilised - UHMWPE, REF 1125243, Sterile, both are components of the Unity Total Knee System. | 2 units | Class II | Terminated | 6 Oct 2021 |
| Z-2612-2021 | Corin Unity Knee Patella, Size 3 / 8.5mm, Centered Dome 3 PEG-UHMWPE, REF 112.018.06, Sterile, a component of the Unity Total Knee System. | 1 unit | Class II | Terminated | 6 Oct 2021 |
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 2021
- 900
- Share of these events in Class II
- 89%
- Product records in this event
- 10Median 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 |
| 31 Oct 2022 | Unity Total Knee System. Used for knee prosthesis in total knee replacement | Device | Class II | 1 |
| 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 |
| 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-2603-2021The 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 88589. https://recallregister.com/fda/ii/88589/. 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 Nationwide distribution in the states of AZ, CA, FL, IL, OK, PA, TX, UT, and WI.
- What quantity of product is in FDA event 88589?
- The event has 10 product records. The first record gives this quantity:
5
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2021 have the same class?
- 89% of the 900 device events that started in 2021 are in Class II.