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Terminated

Duration packaging distributed by Stryker Orthopaedics, Limerick, Ireland Stryker Ireland Carrigtwohill Industrial Estate Carrigtwohill County Cork, Ireland Product Usage: Orthopaedic implants utilized for primary and revision hip and knee (total and unilateral); total shoulder and elbow replacement; replacement; and oncological surgical procedures related to tumor resection. All devices are manufactured from UHMWPE and are processed through post-sterilization (gamma irradiation) heat treatment for stabilization (i.e. Duration process). Launched in 1996, Duration Stabilized Polyethylene is produced by a patented process utilizing a combination of nitrogen packaging to reduce shelf oxidation, gamma irradiation (3Mrads) to sterilize and crosslink the polyethylene, and a post-irradiation stabilization step during which the components undergo a heat treatment process to promote further crosslin king and to enhance product wear resistance. In order to maintain the nitrogen environment over the shelf-life of the product, the packaging consists of double, nested PET blisters sealed with foil (non-gas permeable) Iidstock.

FDA Recall Z-0931-2012 · Posted 2012-01-30

Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeMEH
Date Initiated2011-09-06
Date Terminated2015-11-17
Product Quantity39,483 units

Reason for Recall

As part of Stryker's quality process, a packaging discrepancy was identified in specific lots of Stryker's Duration packaging.

Firm Action

Stryker sent an Urgent Product Recall notification letter and Product Recall Acknowledgment Form dated September 6, 2011 to all affected consignees via FedEx with return receipt. The letter identifed the product, problems, potential hazard, and instructions on how to handled the affected product. Consignees are instructed to Return the affected product to the attention of Regulatory Compliance, Stryker Orthopaedics. Consignees are advised to completed and fax back the attached Product Recall Acknowledgment Form within 5 days to (201) 831-6069. For questions call (201) 972-2100.

Root Cause

Packaging

Distribution Pattern

Nationwide Distribution (USA)

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K112556ADM AND ADM/MDM DURATION INSERTS, ADM AND ADM/MDM X3 INSERTSHowmedica Osteonics Corp. · 2011-09-28

Official Source

View FDA Recall →

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

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