Food, drugs, devices › Corin Ltd
Device recall: Corin BIOLOX DELTA MOD HEAD,032mm, EX LONG +7mm, REF 104.3215
FDA enforcement event 91183 is a device recall by Corin Ltd of Cirencester, initiated 8 Nov 2022 and classified Class II, with 2 product records.
FDA defines Class II as 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. 88% of the 839 device enforcement events initiated in 2022 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Corin Ltd has 8 enforcement events on this register, with a median of 2 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Corin Ltd, Cirencester, United Kingdom.
Reason for recall
"The BIOLOX Delta Ceramic Head size 36XL is labelled as the size 32XL and vice-versa."
Distribution
"US Nationwide distribution in the states of FL, GA, MA, MI, Ok, PA, TX."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0726-2023 | Corin BIOLOX DELTA MOD HEAD,032mm, EX LONG +7mm, REF 104.3215 | 5 units | Class II | Ongoing | 28 Dec 2022 |
| Z-0727-2023 | Corin BIOLOX DELTA MOD HEAD, 036mm EX LONG +8mm, REF 104.3615 | 12 units | Class II | Ongoing | 28 Dec 2022 |
Context
Other enforcement events for Corin Ltd
| 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 |
| 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 |
| 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 |
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The BIOLOX Delta Ceramic Head size 36XL is labelled as the size 32XL and vice-versa."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is 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.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide distribution in the states of FL, GA, MA, MI, Ok, PA, TX."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.