Stryker brand Intra-Compartmental (STIC) Pressure Monitor, Model 295-001-000.
FDA device recall Z-0034-06 · posted 2005-10-12 · Terminated
Recall details
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation
- Reason for recall
- The pressure indicated may be inaccurate, and this inaccuracy may be not detectable by the user.
- Action taken
- Consignees were notified by recall letter dated August 5, 2005 to locate the affected serial numbers and to return the product to the firm.
- Root cause
- Other
- Status
- Terminated
- Product code
- LXC
- Quantity affected
- 473
- Distribution
- Nationwide, Argentina, Australia, Canada, Costa Rica, England, France, Germany, Hong Kong, India, Indonesia, Japan, Netherlands, New Zealand, South Africa, Spain, Sweden, Switzerland, Taipei, Turkey a
- Date initiated
- 2005-07-22
- Date posted
- 2005-10-12
- Date terminated
- 2006-02-15
- Location
- Kalamazoo, MI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| COMPARTMENT SYNDROME PRESSURE MONITOR SYS (K844214) | Stryker Corp. | 1985-04-04 |