FDA Medical Device Recalls (openFDA)
Stryker Howmedica Osteonics Corp.: X-Celerate Instrumentation Punch Thru Tibial Base Plate, Catalog numbers: 3750-0003. 3750-0004, 3750-0005, 3740-0006, 3750-0007, 3750-0009, 3750-0011, 3750-0013; Stryker Howmedica Osteonics Corp Scorpio Total Knee System
- Recall number
- Z-2119-2010
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Product
- X-Celerate Instrumentation Punch Thru Tibial Base Plate, Catalog numbers: 3750-0003. 3750-0004, 3750-0005, 3740-0006, 3750-0007, 3750-0009, 3750-0011, 3750-0013; Stryker Howmedica Osteonics Corp Scorpio Total Knee System
- Status
- Terminated
- Initiated
- 2010-04-05
- Posted
- 2010-08-02
- Terminated
- 2012-08-28
- Reason
- The locating pins on the Punch Thru Tibial Baseplates could break or disassociate from the main body of the instrument.
- Root cause
- Device Design
- Action
- 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.
- Quantity
- 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, Japan, Chile, Brazil, Colombia, Mexico, Panama, Argentina, and Uruguay.
- Lot, serial or model codes
- Catalog numbers: 3750-0003. 3750-0004, 3750-0005, 3740-0006, 3750-0007, 3750-0009, 3750-0011, 3750-0013; All lots.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LXH
- Firm FEI
- 3003070421
- Firm city
- Mahwah
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28