CLASS II ONGOING Device recall · Reported 17 Aug 2022 · FDA Enforcement Report
Metafix Hip Stem, Size 3, Standard, 135 degrees recalled by Corin
Corin is recalling Corin Metafix Hip Stem, Size 3, Standard, 135 degrees, Collared Hip Stem, Cementless, distributed nationwide in the US. The recall was initiated on 22 Jul 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1509-2022
- FDA event ID
- 90573
- Recalling firm
- Corin, Cirencester
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 22 Jul 2022
- FDA classified
- 9 Aug 2022
- Reported
- 17 Aug 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Hip & Knee Implants
Timeline
| 22 Jul 2022 | Recall initiated by company | |
| 9 Aug 2022 | Classified by FDA | +18 days |
| 17 Aug 2022 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
One MetaFix size 7 collarless stem from batch 478179 which was incorrectly labelled as a MetaFix size 3 collared stem from batch 485630.
Product as listed by the FDA
Corin METAFIX HIP STEM, SIZE 3, STANDARD, 135 degrees, COLLARED HIP STEM, CEMENTLESS, Part Number 579.0103
Where it was distributed
US Nationwide distribution in the states of OK, TX, FL.
Questions about this recall
Is Metafix Hip Stem, Size 3, Standard, 135 degrees, Collared Hip Stem, Cementless recalled?
Yes. Corin recalled Metafix Hip Stem, Size 3, Standard, 135 degrees, Collared Hip Stem, Cementless on 22 Jul 2022. The recall is Class II and its status is Ongoing. Recall number Z-1509-2022.
Why was it recalled?
One MetaFix size 7 collarless stem from batch 478179 which was incorrectly labelled as a MetaFix size 3 collared stem from batch 485630.
Which lots are affected?
UDI (01) 0 505563 89123 0 (10) 485630 (17) 261114, Lot Number 485630
Where was it sold?
US Nationwide distribution in the states of OK, TX, FL.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Hip & Knee Implants recalls
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|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Nitrosamine Impurity | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Lead & Heavy Metals | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |