FDA Medical Device Recalls (openFDA)
Stryker Howmedica Osteonics Corp.: Stryker Orthopaedics Sterile Knee Instrument, Patella Cutter; Stainless Steel, Disposable; Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 33 mm size, One single unit to a package. Note: The 30 mm instruments were not distributed. The patella cutters are components of the Xcelerate Instruments and are used with additional devices to remove bone from the patella in preparation for a replacement implant. The Xcelerate Patella Reaming Instruments provide a means to prepare for implantation of either the Duracon or Scorpio Total Knee Systems patellar implants.
- Recall number
- Z-0529-2010
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Product
- Stryker Orthopaedics Sterile Knee Instrument, Patella Cutter; Stainless Steel, Disposable; Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 33 mm size, One single unit to a package. Note: The 30 mm instruments were not distributed. The patella cutters are components of the Xcelerate Instruments and are used with additional devices to remove bone from the patella in preparation for a replacement implant. The Xcelerate Patella Reaming Instruments provide a means to prepare for implantation of either the Duracon or Scorpio Total Knee Systems patellar implants.
- Status
- Terminated
- Initiated
- 2009-11-11
- Posted
- 2009-12-15
- Terminated
- 2010-08-30
- Reason
- Disposable Patella Cutters - 30 mm (catalog number 8000-0030, lot V31257001) were packaged and labeled as 33 mm Disposable Patella Cutters (catalog number 8000-0033, lot V31257001 and vice versa.
- Root cause
- Labeling mix-ups
- Action
- An "Urgent Product Recall" letter dated November 11, 2009 was sent to all affected Stryker branches, hospital risk management, hospital Chief or Orthopaedics and surgeons by Federal Express. The letter described the issue, potential hazards and risk mitigation factors and requested that the Recall Acknowledgement form be completed and returned. The Recall Acknowledgement form has information regarding the return of affected product to the firm. Direct questions to Stryker Orthopaedics by calling 1-201-831-5832.
- Quantity
- 12
- Distribution
- Nationwide Distribution (MA, NJ, FL, TN, OR and NY).
- Lot, serial or model codes
- Catalog Number 8000-0033; Lot code V31257001.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HTS
- 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
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
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