Stryker Orthopaedics Baseplate Impactor Extractor TRIATHLON… — Class II medical device recall Z-1061-2013
Terminated recall by Stryker Howmedica Osteonics Corp., reported 2013-04-17, distributed nationwide. Stryker received reports from the field indicating that the handle detached from the cam of the Baseplate Impa
| Recall number | Z-1061-2013 |
|---|---|
| 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 | 2013-02-23 |
| Classified | 2013-04-05 |
| Reported by FDA | 2013-04-17 |
| Terminated | 2015-06-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, CH, CN, ES, FR, GB, IT, JP, NL, NZ, PL, SE |
| Quantity | 871 units |
| Reason classes | device malfunction |
| Lot numbers | RD4V204, RD5V234, RD5V235, RD5V235A, RD5V235Y, RD5V236, RD5V236A, RD5V237, RD6A009, RD6A010, RD6A011, RD6A011P, RD6A012, RD6A051, RD6A052, RD6A053, RD6A053M, RD6A053T, RD6A061, RD6A061A, RD6A062, RD6A062N, RD6A063, RD6A063T, RD6A065, RD6A065D, RD6A065T, RD6A066, RD6A066A, RD6C103, RD6C103L, RD6C104, RD6C104Y, RD6C105, RD6C105M, RD6C105T, RD6C106, RD6C106A, RD6C108, RD6C109 and 60 more |
| Model numbers | 6541-4-805 |
Product
Stryker Orthopaedics Baseplate Impactor Extractor TRIATHLON Instruments. Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA A subsidiary of Stryker Corporation. Made in USA. Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 MEYZIEU Cedex France The Baseplate Impactor Extractor is intended to securely attach to the tibial baseplate or baseplate trial for impaction and extraction during surgery.
Reason for recall
Stryker received reports from the field indicating that the handle detached from the cam of the Baseplate Impactor/Extractor Assembly.
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-1061-2013. 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.