Microport Recalls PATH Thread Cup Adaptors Due to Removal Difficulty
Microport Orthopedics is recalling 140 units of PATH Thread Cup Adaptors because they may be difficult to remove from the impaction handle during 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: The recall is classified as FDA Class II, and the hazard involves a functional defect during surgery that poses a risk of harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Microport Orthopedics INC. is recalling 140 units of the PATH(R) THREAD CUP ADAPTOR, REF 2007-0013. This orthopaedic surgical instrument is distributed nationwide. The affected lot numbers are 1153896, 1279714, 1288604, and 1314793.
The recall is being conducted because the cup adaptor may be difficult to remove from the impaction handle during surgery. This issue is classified as an FDA Class II recall, indicating a reasonable probability that use of the product could cause temporary or medically reversible adverse health consequences.
Healthcare providers and facilities that have purchased these specific lot numbers should stop using the affected devices and contact Microport Orthopedics for further instructions on the recall process.
The recalled product
- Product
- PATH(R) THREAD CUP ADAPTOR, REF 2007-0013, Wright Medical Technology, Inc. Orthopaedic surgical instrument.
- Manufacturer
- Microport Orthopedics INC.
- Affected units
- 140
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)
- Lot Number(s): 1153896
- 1279714
- 1288604
- and 1314793
Distribution
Distributed nationwide across the United States.
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