X-Celerate Instrumentation Punch Thru Tibial Base Plate, Catalog numbers: 3750-0003. 3750-0004, 3750-0005, 3740-0006, 37
FDA device recall Z-2119-2010 · posted 2010-08-02 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- The locating pins on the Punch Thru Tibial Baseplates could break or disassociate from the main body of the instrument.
- Action taken
- Stryker Urgent Device Correction letters dated April 5, 2010, were sent to all Stryker branches/agencies, hospital Risk Management and surgeons who have used the product by Federal Express. Questions on the bulletin should be directed to Scott Solis, Product Manager ,Knee Marketing at 201-831-5665.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- LXH
- Quantity affected
- 8276
- Distribution
- Worldwide distribution: USA, China, Taiwan, India, Australia, Korea, Singapore, Germany, France, Spain, Italy, Switzerland, Poland, Romania, South Africa, United Kingdom, Netherlands, Sweden, Turkey,
- Date initiated
- 2010-04-05
- Date posted
- 2010-08-02
- Date terminated
- 2012-08-28
- Location
- Mahwah, NJ
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