Recalls / —

—#40929

Product

Stryker brand Intra-Compartmental (STIC) Pressure Monitor, Model 295-001-000.

FDA product code

LXC — Monitor, Pressure, Intracompartmental

Device class

Class U

Medical specialty

Unknown

510(k) numbers

K844214

Affected lot / code info

Serial numbers 0428702183 through 0518008193.

Why it was recalled

The pressure indicated may be inaccurate, and this inaccuracy may be not detectable by the user.

Root cause (FDA determination)

Other

Action the firm took

Consignees were notified by recall letter dated August 5, 2005 to locate the affected serial numbers and to return the product to the firm.

Recalling firm

Firm

Stryker Instruments Div. of Stryker Corporation

Address

4100 E. Milham, Kalamazoo, Michigan 49001

Distribution

Distribution pattern

Nationwide, Argentina, Australia, Canada, Costa Rica, England, France, Germany, Hong Kong, India, Indonesia, Japan, Netherlands, New Zealand, South Africa, Spain, Sweden, Switzerland, Taipei, Turkey and United Arab Emir.

Timeline

Recall initiated

2005-07-22

Posted by FDA

2005-10-12

Terminated

2006-02-15

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #40929. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.