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Terminated

6.5 Cancellous Bone Screw 25 mm; Responsible Firm on Label: Manufacturer, Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 USA, A Subsidiary of Stryker Corp., Made in USA; Catalog Number: 2030-6525-1 The Omnifit bone screws are intended to augment the fixation of compatible acetabular cups.

FDA Recall Z-2007-2008 · Posted 2008-09-22

Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeHWC
Date Initiated2005-12-20
Date Terminated2008-09-23
Product Quantity29 units

Reason for Recall

The firm has been made aware that one lot of 6.5 Cancellous Bone Screws 25mm was packaged and labeled as 25 mm in length when it maybe 20 mm in length.

Firm Action

The recalling firm sent notification letters and Product Accountability Forms via Fed Ex with return receipt on December 20, 2005. The notification letter described the problem, and asked customers to inventory and quarantine the affected product. Customers were told to return the affected product to Stryker. Contact Stryker at 1-201-831-5825 for assistance.

Root Cause

Labeling mix-ups

Distribution Pattern

nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K894124OMNIFIT SELF TAPPING CANCELLOUS BONE SCREWSOsteonics Corp. · 1989-09-11K873251OMNIFIT BONE SCREWOsteonics Corp. · 1987-09-18

Official Source

View FDA Recall →

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

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