V 40 Femoral Head, Sterile, 22 mm recallZ-1822-2009 · Stryker Howmedica Osteonics Corp. · initiated Jun 18, 2009
Terminated All recalls posted in August 2009
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Stryker Howmedica Osteonics Corp. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Sterilization issue: During post-sterilization inspection of the outer blister packaging of the affected lots, it was determined that the outer blister did not meet the required minimum seal width.
FDA root cause category: Process control
What the company is doing
Urgent Product Recall letters were sent via Federal Express on June 18, 2009 to all Stryker Branches/Agencies, hospital Risk Management, hospital Chief of Orthopaedics and surgeons who may have used the recalled products. The letters stated the issue, potential hazards, and the risk mitigation. Customers may contact Colleen O'Meara at 201-831-5970 with any questions.
Recall details
- Recall number
- Z-1822-2009
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jun 18, 2009
- Posted by the FDA
- Aug 18, 2009
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Quantity
- 13 total, both products.
- Product code
- LWJ
- FDA submissions
- K022077, K993601
- Distribution
- Nationwide Distribution
Product description
V 40 Femoral Head, Sterile, 22 mm; Catalog number 6260-4-122, Catalog number 6260-5-226; Howmedica Osteonics Corp., Stryker Ireland, Carrigtwohill County Cork, Ireland; Intended for use with femoral stems and acetabular components in primary or revision total hip arthroplasty.
Code information (models, lots, serial numbers)
lot # 29213701;Exp. 1/28/2014 and lot # 29228301; Exp 1/28/2014
Other devices under the same FDA submission
17 devices cleared under K022077, K993601 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- C-Taper Head 06-3205Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, uncemented4 reports
- C-Taper Head 06-2800Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, uncemented3 reports
- C-Taper Head 06-3200Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, uncemented3 reports
- Morse Head 01-2200Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, cemented2 reports
- C-Taper Head 06-2210Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented2 reports
- C-Taper Head 06-2805Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, uncemented2 reports
- C-Taper Head 06-2898Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, cemented2 reports
- Morse Head 01-2205Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- Morse Head 01-2800Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- Morse Head 01-2810Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 report
- Morse Head 01-3205Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- C-Taper Head 06-2200Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page