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Terminated

StelKast Proven Knee - Tibial Half Block Augmentation and Screw. Part Number: SC2287-5-5, Size 5, Thickness 5 mm, StelKast, Murray, PA 15317

FDA Recall Z-0483-2008 · Posted 2008-01-23

Recalling FirmStelkast Co
Recall StatusTerminated
Product CodeJWH
Date Initiated2007-10-05
Date Terminated2008-01-23
Product Quantity34 units

Reason for Recall

The screws may fracture

Firm Action

The recalling firm telephoned their customers on 10/5/07 to inform them of the problem and the need to return the product. As a follow up to the telephone calls, the recalling firm issued a recall letter (Field Notification) on 10/9/07 via certified mail.

Root Cause

Device Design

Distribution Pattern

Nationwide: shipped to medical facilities in IL, NC, PA, TN, TX, VA, and WV.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K051976PROVEN REVISION MODULAR TIBIAL TRAYStelkast Company · 2005-10-17

Official Source

View FDA Recall →

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

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