Regard TOTAL HIP surgical implant recalled due to incorrect product identification labeling
ROi CPS LLC is recalling 50 kits of Regard TOTAL HIP implants distributed in Missouri due to incorrect product identification labeling on individual kits. This mislabeling could result in the wrong implant being used in surgery.
The agency’s classification
FDA (Devices): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for a medical device (surgical implant) with mislabeling of product identification. No illnesses, injuries, or deaths have been reported. Per the FDA severity rubric, recalls involving risk-of-harm products such as surgical implants where injury has not yet been reported are classified as High (score 3).
Plain-English summary
ROi CPS LLC is recalling 50 kits of the Regard TOTAL HIP hip replacement system (Item No. 8800297010, Lot No. 90328) due to mislabeling with incorrect product identification on individual kit labels. The affected kits were distributed in Missouri.
Mislabeling with incorrect product identification on surgical implant kits could result in confusion in the operating room or the wrong implant being selected for implantation. This could potentially lead to adverse patient outcomes.
Consumers and healthcare providers who have received these kits should verify the product identification information on their individual kits against product documentation. If you have received this product, contact ROi CPS LLC for instructions on return or replacement. Do not use kits with incorrect product identification for surgery until the issue has been resolved.
The recalled product
- Product
- Regard, TOTAL HIP - SPRINGFIELD, Item No. 8800297010, Case Quantity: 2, Sterile
- Manufacturer
- ROi CPS LLC
- Affected units
- 50
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Item No. 8800297010
- Lot No. 90328
- UDI 10194717113164
Distribution
Distributed in 1 state:
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