Scorpio X3 UHMPWE Tibial Inserts and Scorpio X3 UHMWPE… recallZ-0911-2010 · Stryker Howmedica Osteonics Corp. · initiated Feb 17, 2006
Terminated All recalls posted in March 2010
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
Stryker Orthopaedics became aware of a potential anomaly related to the packaging process of referenced lots of X# polyethylene used on Scorpio, Triathlon and Trident inserts.
FDA root cause category: Process design
What the company is doing
Stryker Orthopaedics issued an "Important Market Withdrawal" notification dated February 17, 2007 via federal express. Consignees were informed of the affected product and asked to retrieve, reconcile and return product via Return Material Authorization to the firm. For further information, contact Stryker Orthopaedics Quality Assurance at 1-201-831-5825.
Recall details
- Recall number
- Z-0911-2010
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Feb 17, 2006
- Posted by the FDA
- Mar 2, 2010
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Quantity
- 594 units total - all products.
- Product code
- JWH
- FDA submissions
- K051977
- Distribution
- Worldwide Distribution -- United States and Canada.
Product description
Scorpio X3 UHMPWE Tibial Inserts and Scorpio X3 UHMWPE Patellar Components, multiple sizes, Stryker Orthopaedics, Mahwah, NJ. Intended to be used with cemented or cementless components in primary or revision total knee arthroplasty.
Code information (models, lots, serial numbers)
Lot Numbers: 35458101; 36121101; 36121401; 36209601; 36209701; 35904301; 35904501; 35904701; 36294401; 36297801; 36605701; 36297902; 36605801; 35904901; 36298101; 35905001; 36298201; 35905101; 35905301; 36295101; 35905501; 36298801; 36298902; 36299301; 35906001; 36007001; 36301001; 36007101; 36301301; 36862701; 36011001; 36606201; 36606401; 36011801; 36301501; 36012201; 36012301; 36301901; 36012901; 36302001; 36013001; 36013401; 36302101; 36302301; 36014501; 36014701A 36014801; V145; V146; V148; V161; V162; V163; V165; V166; V024C and V026C.
Other devices under the same FDA submission
6 devices cleared under K051977 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Scorpio 72-25-1110Howmedica Osteonics Corp. · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER3 reports
- Scorpio 72-25-1112Howmedica Osteonics Corp. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- Scorpio 73-20-0510Howmedica Osteonics Corp. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- Scorpio 73-20-3508Howmedica Osteonics Corp. · PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- Scorpio 72-25-0912Howmedica Osteonics Corp. · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 report
- Scorpio 72-26-0710Howmedica Osteonics Corp. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 50150).
- Z-0909-2010 · TerminatedTrident Acetabular Hip System Polyethylene Inserts, Stryker Orthopaedics, multiple sizes, Mahwah, NJ. Intended for use in cementless fixation fro use in total hip arthroplasty to …
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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