Stradis Healthcare Oral Surgery Implant Packs Recalled for Incomplete Seal Defect
Stradis Medical recalled 20 oral surgery implant packs with incomplete outer bag sealing that may compromise sterility. Affected lot numbers are 22228490663 and 22242491516, distributed in the US and Canada. No illnesses reported.
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: FDA Class II medical device recall for surgical equipment where manufacturing defects may compromise sterility. This constitutes a risk-of-harm product scenario where the hazard is theoretical (incomplete seal may breach sterility) with no illnesses or injuries documented in the source.
Plain-English summary
Stradis Medical, LLC dba Stradis Healthcare is recalling the STRADIS HEALTHCARE Basic Implant Pack, Item No. 40561BIP, a sterile surgical tray kit used in oral surgery. A total of 20 units were affected and distributed to locations throughout the United States and Canada.
The product underwent certain manufacturing conditions that may have resulted in incomplete sealing of the outer bag. If the bag was incompletely sealed, this may result in a breach of the kit's sterility.
The affected lot numbers are 22228490663 and 22242491516. No illnesses or injuries have been reported in connection with this product to date.
The recalled product
- Product
- STRADIS HEALTHCARE, Basic Implant Pack, Item No.40561BIP, oral surgery tray
- Manufacturer
- Stradis Medical, LLC dba Stradis Healthcare
- Category
- Medical Device — Surgical Tray
- Affected units
- 20
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 (4)
- UDI/DI (case) M75240561BIP1
- UDI/DI (kit)M75240561BIP0
- Serial/Lot Numbers: 22228490663
- 22242491516
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 78 recalled by Stradis Medical, LLC dba Stradis Healthcare 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.
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