MicroPort Orthopedics Recalls 48 Schanz Screws Due to Seal Defect
MicroPort Orthopedics is recalling 48 sterile Schanz screws due to an inadequate pouch seal that could compromise sterility and lead to infection.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of serious adverse events, specifically infections, which aligns with the rubric criteria for a Severe rating.
Plain-English summary
MicroPort Orthopedics Inc. is recalling 48 units of the SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R. The recall is due to an inadequate pouch seal, which has the potential to lead to a loss of sterile pouch integrity. This defect could impact the product's sterility assurance and may lead to serious adverse events, including localized and systemic infections.
The affected product is part of the MPO Total Hip Systems, indicated for use in total hip arthroplasty for skeletally mature patients. The recall covers lot 1723305. The products were distributed worldwide, including nationwide in the United States (specifically in TX, AL, AZ, CO, KS, ME, MO, WB, LA, CA, MD, and PR) and in Canada.
Healthcare providers and facilities should stop using the affected Schanz screws and contact MicroPort Orthopedics for further instructions on how to return or dispose of the product.
The recalled product
- Product
- MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R Product Usage: MPO Total Hip Systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following…
- Manufacturer
- MicroPort Orthopedics Inc.
- Hazard
- Affected units
- 48
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)
- lot 1723305
Distribution
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