Matrix Surgical Recalls 42 OmniPore Implants Due to Mislabeling
Matrix Surgical Holdings is recalling 42 OmniPore Surgical Implants due to product mislabeling. The recall covers units distributed in the US and several international countries.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II due to product mislabeling. Per the rubric, minor labeling errors and voluntary precautionary recalls without reported injuries or illnesses are classified as Moderate.
Plain-English summary
Matrix Surgical Holdings, LLC is voluntarily recalling 42 units of the OMNIPORE Surgical Implant Petite Paranasal - Right. The recall was initiated because of product mislabeling. The specific product code is OP9520, and the affected lot number is 00855421005871 022050617.
These implants are intended for nonweight-bearing applications in craniofacial reconstruction, cosmetic surgery, and the repair of craniofacial trauma. The affected units were distributed worldwide, including in the United States (specifically Florida and Massachusetts) and in Argentina, Chile, Colombia, Iran, Mexico, Norway, Taiwan, and Turkey.
The recall was initiated on January 30, 2019, and was terminated on June 23, 2020. The firm notified customers via email. Patients who have had these implants placed should contact their healthcare provider for guidance regarding the mislabeling issue.
The recalled product
- Product
- OMNIPORE Surgical Implant Petite Paranasal - Right - Product Usage: OmniPore Surgical Implants in block, sheet, and anatomical shapes are intended for nonweight bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. OmniPore…
- Manufacturer
- Matrix Surgical Holdings, LLC
- Hazard
- Affected units
- 42
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 (1)
- OP9520 / Lot # 00855421005871 022050617
Distribution
Part of a larger recall action
This product is one of 2 recalled by Matrix Surgical Holdings, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Matrix Surgical Holdings, LLC
See all →- ModerateMatrix Surgical Recalls 46 OmniPore Implants Due to Mislabeling
FDA (Devices) · 2019-05-08
- ModerateMatrix Surgical Recalls Mislabelled Mandible Onlay Implants
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