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Terminated

Synthes In Situ Bender/Cutter Kit-Wide-Sterile. Catalog Number 530.521S.

FDA Recall Z-0825-2010 · Posted 2010-02-24

Recalling FirmSynthes USA (HQ), Inc.
Recall StatusTerminated
Product CodeHRS
Date Initiated2010-01-06
Date Terminated2010-10-06
Product Quantity187 units

Reason for Recall

There is the potential for the bender/cutter attachment to continue heating after release of the power button. There is potential for patient and/or staff injury if continuous heating is unrecognized.

Firm Action

An "Urgent: Medical Device Recall" letter dated January 8, 2010 was issued to customers via USPS Certified mail. The letter described the issue and affected product. Customers were notified to cease use of the recalled product, examine inventory and follow instructions for return to the firm as indicated in the recall letter. For questions, please call 1-800-620-7025 x 5452 or 1-610-719-5452 or contact your Synthes CMF Sales Consultant.

Root Cause

Other

Distribution Pattern

Nationwide Distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K021458SYNTHES IN-SITU BENDER/CUTTERSynthes (Usa) · 2002-07-24

Official Source

View FDA Recall →

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

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