Z-1642-2009

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

Name: Z-1642-2009 Restoration Modular Cone Bodies; titanium Alloy and Hydroxyapatite, Sterile. Catalog number 6276-1-021...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2009-04-02
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2009-04-02 / Terminated / root cause: manufacturing process

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Restoration Modular Cone Bodies; titanium Alloy and Hydroxyapatite, Sterile. Catalog number 6276-1-021, Catalog number 6276-1-025, Catalog number 6276-1-219... on 2009-04-02. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1642-2009
Status: Terminated
Initiated: 2009-04-02
Posted: 2009-05-21
Terminated: 2012-08-27
Recalling firm: Howmedica Osteonics Corp
Product: Restoration Modular Cone Bodies; titanium Alloy and Hydroxyapatite, Sterile. Catalog number 6276-1-021, Catalog number 6276-1-025, Catalog number 6276-1-219, and Catalog number 6276-1-325. Howmedica Osteonics Corp, Stryker Ireland, Carrighwohill Sterile. Intended Use: For primary or revision total hip arthroplasty and severe proximal bone loss. Stems are intended to be used with Howmedica Osteonics femoral heads, unipolar and bipolar components, and acetabular components. Conditions for which product may be appropriate for use: rheumatoid arthritis, correction of deformity, non-inflammatory degenerative joint disease, revision surgery, treatment of non-union, fracture of proximal femur with head involvement.
Product code: LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 17 units
Distribution: Nationwide Distribution
Product codes and lots: Lot # 211080002; Lot # 22109602; Lot # 21883201; Lot # 21910302 and 21883401.

Product code LZO

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)