Stryker Recalls SERFAS 90 Degree Energy Probes Due to Fragmentation
Stryker Endoscopy is recalling 22,063 SERFAS 90 degree Energy Probes because fragments of the probe have been reported to break off into patients during arthroscopic procedures.
What this means for you
Illness, injury, or structural failure has been reported. 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 structural defect where probe fragments break off into patients, which aligns with the rubric criteria for significant injury or structural defects.
Plain-English summary
Stryker Endoscopy is recalling 22,063 units of the SERFAS 90 degree Energy Probe, Part Number 279-350-101. The recall covers all non-expired product with lot numbers ranging from 13128AE2 through 14337AE2. These devices are indicated for arthroscopic procedures of the knee, shoulder, ankle, hip, elbow, and wrist, specifically for the resection, ablation, and coagulation of soft tissue, as well as the hemostasis of blood vessels.
The recall was initiated due to reports that fragments of the probe broke off and remained in the patient. The agency has classified this as a Class II recall. The affected devices were distributed worldwide, including nationwide in the United States and internationally to Argentina, Australia, Bolivia, Brazil, Chile, China, Colombia, Hong Kong, India, Italy, Japan, Republic of Korea, Malaysia, Netherlands, Poland, Romania, Singapore, South Africa, Spain, Sweden, Switzerland, United Arab Emirates, and the United Kingdom.
Healthcare facilities and consumers should stop using the affected devices immediately. Stryker Endoscopy is the recalling firm responsible for managing the recall.
The recalled product
- Product
- SERFAS 90 degree Energy Probe, Part Number 279-350-101; SERFAS Energy Probes are indicated for arthroscopic procedures of the knee, shoulder, ankle, hip, elbow and wrist. Specifically, the probes are used for resection, ablation and coagulation of soft tissue, as well as the h
- Manufacturer
- Stryker Endoscopy
- Affected units
- 22,063
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 (3)
- Part number 279-350-101
- All non expired product
- lot numbers 13128AE2 through 14337AE2.
Distribution
Distributed nationwide across the United States.
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