Stryker Orthopaedics Patella Assembly Instrument — Class II medical device recall Z-2789-2016
Terminated recall by Stryker Howmedica Osteonics Corp., reported 2016-09-21, distributed nationwide. Upon failure of the press-fit, the clamping sub components and pins could disassociate from the Scorpio Patell
| Recall number | Z-2789-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Howmedica Osteonics Corp., Mahwah, NJ, United States |
| Recall initiated | 2016-08-01 |
| Classified | 2016-09-13 |
| Reported by FDA | 2016-09-21 |
| Terminated | 2017-06-08 |
| Distributed | Nationwide (US) |
| Quantity | 2,039 units |
| UPC / GTIN / UDI-DI | 07613327215854 |
| Lot numbers | RD2H056, RD2H056E, RD2K017, RD2K017E, RD2K049, RD2K049E, RD2K049H, RD2K049R, RD2K049S, RD2K056, RD2K056E, RD2K056S, RD2K065, RD2K065E, RD2K065S, RD2K068, RD2K068B, RD2K068E, RD2K068S, RD2K068W, RD2K068X1, RD2M003, RD2M003H, RD2M019, RD2M019E, RD2M019H, RD2M038, RD2M038H, RD2M039, RD2N030, RD2N030E, RD2N030K, RD2N030S, RD2N030X, RD2N030X1, RD2N030XX, RD2T037, RD2T037A, RD2T037W, RD2T037X and 160 more |
| Model numbers | 3182-1000 |
Product
Stryker Orthopaedics Patella Assembly Instrument, REF 3182-1000, Non-Sterile, NDC (01) 07613327215854 (10) The Scorpio Patella Assembly Instrument is used during total knee replacement surgery for the implantation of Scorpio Patella implant components. The device functions to fully seat the implant onto the bone and secure it in position while the surgeon removes any excess cement and when cement polymerization occurs.
Reason for recall
Upon failure of the press-fit, the clamping sub components and pins could disassociate from the Scorpio Patella Assembly Instrument.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2789-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.