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Terminated

Stryker Xia Precision System; Jam Shidi 11 Gauge 5 inch; Sterile; Manufactured for: Stryker Spine SAS, Cestas, France; Distributed in the US by Howmedica Osteonics Corp, 325 Corporate Drive, Mahwah, NJ. Intended for use as a manual surgical instrument during percutaneous posterior, non-cervical pedicle fixation.

FDA Recall Z-0791-2010 · Posted 2010-02-16

Recalling FirmStryker Spine
Recall StatusTerminated
Product CodeLXH
Date Initiated2010-01-18
Date Terminated2012-09-06
Product Quantity2717, all sizes

Reason for Recall

Stryker Spine received reports of packaging failures during shipping for the Jam Shidi instruments, which may compromise the sterility of the product.

Firm Action

Stryker Spine issued an "Urgent Product Recall" notification dated January 15, 2010 via Federal Express to all consignees. The letter informed users of the issue and potential hazards of the affected product. For further information, contact your local Stryker Spine Sales Representative or call 201-760-8206.

Root Cause

Package design/selection

Distribution Pattern

Nationwide distribution.

Official Source

View FDA Recall →

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

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