Stryker Howmedica Osteonics, Skirtless 5 40' LFIT V40… recallZ-0391-2010 · Stryker Howmedica Osteonics Corp. · initiated Sep 4, 2009
Terminated All recalls posted in November 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
Packaging mix up between the Taper V40 Femoral Head and the LFIT V40 Femoral Head.
FDA root cause category: Process control
What the company is doing
Stryker sent Notification letters and Product Accountability Forms via FedEx on September 4, 2009 with return receipt. Corrected letters were sent on September 9, 2009.
Recall details
- Recall number
- Z-0391-2010
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Sep 4, 2009
- Posted by the FDA
- Nov 23, 2009
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Quantity
- 10 units
- Product code
- JDG
- FDA submissions
- K010757, K022077, K061434, K993601
- Distribution
- Nationwide distribution.
Product description
Stryker Howmedica Osteonics, Skirtless 5 40' LFIT V40 Femoral Head (32 mm +0 mm offset); hip prosthesis component.
Code information (models, lots, serial numbers)
Catalog number 6260-9-132; Lot Code 28759003
Other devices under the same FDA submission
22 devices cleared under K010757, K022077, K061434, 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
- LFIT 06-3625Howmedica Osteonics Corp. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS 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
Other products in the same recall event
The FDA groups related products into one recall event (event 53434).
- Z-0390-2010 · TerminatedStryker Howmedica Osteonics, Skirted 5 40' Taper V40 Femoral Head (26 mm +8mm offset), hip prosthesis component.
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.
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