Restoration Modular Cone Bodies; titanium Alloy and Hydroxyapatite, Sterile. Catalog number 6276-1-021, Catalog number 6

FDA device recall Z-1642-2009 · posted 2009-05-21 · Terminated

Recall details

Recalling firm

Stryker Howmedica Osteonics Corp.

Reason for recall

Packaging burst test values for the Restoration Modular Cone Body family were found to be incorrectly transferred from the finalized validation to the work specification. Testing showed that burst test results for recalled products fell below the validated parameters.

Action taken

Urgent Product Recall letters were sent via Federal Express on April 2, 2009 to Stryker branches, Chief of Orthopaedics, Hospital Rick Management and Surgeons. The letter stated the issue, the potential hazards, and the risk mitigation. Customers were asked to examine their inventory and hospital locations to identify the affected products; retrieve all effected products and return it to their branch or agency warehouse for reconciliation; reconcile all products on the attached Product Accountability Form and fax a copy to the number listed; return the affected product via the Inter-Org Transfer and ship it to the attention of the individual listed; attach the fluorescent orange PRODUCT REMEDIATION sticker to their return, indicating the Product Remediation #, and mark the box with the words "PRODUCT RECALL". Questions should be directed to Colleen O'Meara at 201-831-5970.

Root cause

Process control

Status

Terminated

Product code

LZO

Quantity affected

17 units

Distribution

Nationwide Distribution

Date initiated

2009-04-02

Date posted

2009-05-21

Date terminated

2012-08-27

Location

Mahwah, NJ

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