FDA Medical Device Recalls (openFDA)
Stryker Howmedica Osteonics Corp.: CuttingEdge Total Hip Instrumentation Surgical Protocol; Acetabular and Femoral Surgical Technique for Primary Press Fit and Cemented Hip Implants. Stryker Howmedica Osteonics. Surgical protocols instruct surgeons on proper surgical technique.
- Recall number
- Z-0505-2010
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Product
- CuttingEdge Total Hip Instrumentation Surgical Protocol; Acetabular and Femoral Surgical Technique for Primary Press Fit and Cemented Hip Implants. Stryker Howmedica Osteonics. Surgical protocols instruct surgeons on proper surgical technique.
- Status
- Terminated
- Initiated
- 2009-08-31
- Posted
- 2010-01-11
- Terminated
- 2013-07-17
- Reason
- Certain surgical protocols do not provide specific instructions for initiating power to the calcar planer prior to engagement with bone.
- Root cause
- Error in labeling
- Action
- "Urgent Product Correction - Surgical Protocol" letters and Product Accountability Forms were sent to consignees via Fed Ex on August 31, 2009 and September 1, 2009 with return receipt. Notification letters described the issue, protocols affected, potential hazard and harm and risk mitigation. Direct questions about the recall by calling 1-201-972-2100 or Customer Service 1 -866-OR-ASSIST (1 -866-672-7747).
- Quantity
- 1,362
- Distribution
- Worldwide Distribution.
- Lot, serial or model codes
- Catalog Number/Code Number: LSP42.
- 510(k) numbers
- ["K022555"]
- PMA numbers
- not on file
- Product code
- LZO
- 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