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Terminated

Stelkast Unicondylar Knee Femoral Component SC2462-1. Used for moderate joint impairment from painful arthritis (rheumatoid, osteo and/or post-traumatic; revision of failed unicompartmental knee implant or other procedure; and alternative to tibial osteotomy in patients with unicompartmental arthritis.

FDA Recall Z-0371-2010 · Posted 2009-11-20

Recalling FirmStelkast Co
Recall StatusTerminated
Product CodeHSX
Date Initiated2009-05-05
Date Terminated2009-11-20
Product Quantity20 units

Reason for Recall

incorrect size markings on component

Firm Action

The recalling firm telephoned the medical supply companies on 5/5-19/09 to inform them of the problem and the need to return the products. If there are questions regarding this issue, please call 1.888.273.1583.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K032824STELKAST UNICONDYLAR KNEE SYSTEMStelkast Company · 2003-11-13

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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