SERFAS 90 degree Energy Probe, Part Number 279-350-101; SERFAS Energy Probes are indicated for arthroscopic procedures o
FDA device recall Z-1831-2015 · posted 2015-06-24 · Terminated
Recall details
- Recalling firm
- Stryker Endoscopy
- Reason for recall
- Stryker Endoscopy is recalling all non expired SERFAS 90 degree Energy Probes due to reports of fragments of the probe breaking off into the patient.
- Action taken
- Stryker sent an Urgent Medical Device Recall letter dated June 5, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to do the following: 1. Inform individuals within their organization who need to be aware of this device removal. 2. Review inventory of lots of part number 279-350-101 and determine if you have the affected product (all non-expired devices) in stock. Response is required. 3. If no product is found, complete acknowledgement form located on the Stryker Endoscopy recall website endorecall.stryker.com by logging in using the account number and zip code on this letter. 4. If you do have product, segregate the product and call Stryker customer service at 1-800-624-4422 Option 3 to arrange for product return and issuance of credit. For questions regarding this recall call 408-754-2664.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 22,063 devices
- Distribution
- Worldwide Distribution - US (nationwide) and Internationally to US Argentina, Australia, Bolivia, Brazil, Chile, China, Colombia, Hong Kong, India, Italy, Japan, Republic of Korea, Malaysia, Netherlan
- Date initiated
- 2015-06-03
- Date posted
- 2015-06-24
- Date terminated
- 2016-02-10
- Location
- San Jose, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SERFAS ENERGY SYSTEM (K041810) | Stryker Endoscopy | 2004-12-21 |