FDA Medical Device Recalls (openFDA)
Stryker Howmedica Osteonics Corp.: Scorpio Adjustable Femoral A/P Sizing Guide Assembly; non-sterile instruments; Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430; A subsidiary of Stryker Corporation The A/P sizer is designed to set the desired external rotation and to provide adjustment of the anterior/posterior position when needed.
- Recall number
- Z-0927-2011
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Product
- Scorpio Adjustable Femoral A/P Sizing Guide Assembly; non-sterile instruments; Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430; A subsidiary of Stryker Corporation The A/P sizer is designed to set the desired external rotation and to provide adjustment of the anterior/posterior position when needed.
- Status
- Terminated
- Initiated
- 2010-09-27
- Posted
- 2011-01-19
- Terminated
- 2013-07-31
- Reason
- Stryker Orthopaedics has become aware that there is a potential for the shoulder screw on the Scorpio Sizing Guide (the "Sizing Guide") to disassociate from the main body of the instrument.
- Root cause
- Device Design
- Action
- Stryker Orthopaedics sent an 'Urgent Update Product Recall' letter dated December 30, 2010, along with Product Acknowledgement forms to all customers (US and international). The letter described the product, problem and action to be taken by the customers. The customers were asked to complete and return the PRODUCT RECALL ACKNOWLEDGMENT FORM within five (5) days via fax at 201-831-6069; contact the hospitals in their territory that have the affected product to arrange return of the product; and return the affected product to the attention of Regulatory Compliance, Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. If you have any questions, feel free to contact the Manager, Divisional Regulatory Compliance at (201) 972-2100 or the Associate Product Manager, Knee Marketing Team, at (201) 831-5028.
- Quantity
- 237 units
- Distribution
- Worldwide distribution: USA and countries including: Australia, Brazil, China, Columbia, France, Greece, India, Italy, Korea, Poland, Singapore, South Africa, and United Kingdom.
- Lot, serial or model codes
- Catalog Number 8000-0313 Lot numbers: RD2M081 RD2MO80 RD2N006 RD2N006E RD2L054 RD2M080E RD2S005X1 RD2S005 RD2S060 RD2N006S RD2S060S RD2S059 RD2V064 RD2V063 RD2V067 RD2V068 RD2V067A RD2V064E RD2V068S RD3A027 RD3A027M RD2V067M RD3A011 RD3A010 RD3A010A RD2VO68M RD3A011H RD3A009 RD2V068H RD3A027H RDA070H RD3A069 RD3A069H RD3A070 RD3L033 RD3N205 RD3N205X1 RD3S020 RD3S094 RD3V086
- 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