Matrix Surgical Recalls 46 OmniPore Implants Due to Mislabeling
Matrix Surgical Holdings is voluntarily recalling 46 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 and involves product mislabeling, which aligns with the rubric for moderate severity involving minor labeling errors or voluntary precautionary recalls without reported injuries.
Plain-English summary
Matrix Surgical Holdings, LLC is voluntarily recalling 46 units of OMNIPORE Surgical Implant Petite Paranasal - Left. The recall was initiated because of product mislabeling. These implants are intended for nonweight bearing applications of craniofacial reconstruction, cosmetic surgery, and repair of craniofacial trauma.
The affected products are identified by code OP9519 and Lot # 00855421005864 021050617. The recall was initiated on January 30, 2019, and was terminated on June 23, 2020. The FDA classified this recall as Class II.
The products were distributed worldwide, including in the United States (specifically Florida and Massachusetts) and in Argentina, Chile, Colombia, Iran, Mexico, Norway, Taiwan, and Turkey. The firm notified customers via email. Consumers and healthcare providers should check their inventory for the specific lot number and contact the manufacturer for further instructions.
The recalled product
- Product
- OMNIPORE Surgical Implant Petite Paranasal - Left - 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
- 46
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)
- OP9519 / Lot # 00855421005864 021050617
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 42 OmniPore Implants Due to Mislabeling
FDA (Devices) · 2019-05-08
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