CLASS II Device recall · Reported 9 Mar 2022 · FDA Enforcement Report
Regard, Total Hip - Springfield recalled by ROi CPS
ROi CPS is recalling Regard, Total Hip - Springfield, distributed in Missouri. The recall was initiated on 13 Jan 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-0693-2022
- FDA event ID
- 89471
- Recalling firm
- ROi CPS, Republic, MO
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Jan 2022
- FDA classified
- 28 Feb 2022
- Reported
- 9 Mar 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Labeling Errors
- Device type
- Hip & Knee Implants
Timeline
| 13 Jan 2022 | Recall initiated by company | |
| 28 Feb 2022 | Classified by FDA | +46 days |
| 9 Mar 2022 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Products are mislabeled with the incorrect product identification on individual kit labeling.
Product as listed by the FDA
Regard, TOTAL HIP - SPRINGFIELD, Item No. 8800297010, Case Quantity: 2, Sterile
Where it was distributed
Missouri
Questions about this recall
Is Regard, Total Hip - Springfield recalled?
Yes. ROi CPS recalled Regard, Total Hip - Springfield on 13 Jan 2022. The recall is Class II and its status is Terminated. Recall number Z-0693-2022.
Why was it recalled?
Products are mislabeled with the incorrect product identification on individual kit labeling.
Which lots are affected?
Item No. 8800297010; Lot No. 90328; UDI 10194717113164
Where was it sold?
Missouri
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.
More recalls from ROi CPS
All 86| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | regard Item Number: 830106006, LD01114F - Newborn Kit containing recalled | ROi CPS | Potency & Assay | MO |
| Device | CLASS II | regard Clinical Packaging Solutions, HT00376I - Special Procedure recalled | ROi CPS | Packaging Defects | Nationwide |
| Device | CLASS II | Regard Kit containing the Microtek decanter recalled by ROi CPS | ROi CPS | Sterility | Nationwide |
| Device | CLASS I | regard Operative LAP recalled by ROi CPS | ROi CPS | Other | LA |
| Device | CLASS I | Regard Dressing change kit recalled by ROi CPS | ROi CPS | Other | Nationwide |
Other Hip & Knee Implants recalls
All 3,097| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 |