Stryker Precision Pointer Electromagnetic Recalled for Potential Fracture During Use
Stryker Leibinger is recalling 513 Precision Pointer Electromagnetic devices because they may fracture during use, potentially releasing loose parts inside a patient.
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 device may fracture during use, potentially releasing loose parts inside a patient. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Stryker Leibinger GmbH & Co. KG is recalling 513 units of the Precision Pointer Electromagnetic (model 8000-050-001). The recall covers Lot 7000413361 with UDI-DI 07613327413205. The devices were distributed worldwide, including in the United States and various countries in Europe, Asia, and North America.
The recall was initiated because the device may fracture during use at the laser welded joint on the pointer tube. If this fracture occurs, loose parts may fall out of the product while the device is inside a patient. The source text does not report any illnesses, injuries, or deaths associated with this defect.
Healthcare providers and consumers should stop using the affected devices immediately. Users should contact Stryker Leibinger for instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- Precision Pointer Electromagnetic (8000-050-001)
- Manufacturer
- Stryker Leibinger GmbH & Co. KG
- Hazard
- Affected units
- 513
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 7000413361 UDI-DI 07613327413205
Distribution
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