Stryker Orthopaedics Duracon Flat Tibial Wedge Cemented use only… — Class II medical device recall Z-0362-2016
Terminated recall by Stryker Howmedica Osteonics Corp., reported 2015-12-09, distributed nationwide. Stryker Orthopaedics has received two customer complaints regarding Duracon Tibial Wedge implants puncturing t
| Recall number | Z-0362-2016 |
|---|---|
| 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 | 2015-09-21 |
| Classified | 2015-12-02 |
| Reported by FDA | 2015-12-09 |
| Terminated | 2017-06-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, CH, DE, ES, HK, IT, JP, MY, NL, NZ, PL, RO, SE |
| Quantity | 2,577 units |
| Model numbers | 6630-6-105, 6630-6-110, 6630-6-125, 6630-6-130, 6630-6-150, 6630-6-155, 6630-6-170, 6630-6-175, 6630-6-205, 6630-6-210, 6630-6-225, 6630-6-230, 6630-6-250, 6630-6-255, 6630-6-270, 6630-6-275, 6630-6-305, 6630-6-310, 6630-6-325, 6630-6-330, 6630-6-350, 6630-6-355, 6630-6-370, 6630-6-375, 6630-6-405 and 7 more |
Product
Stryker Orthopaedics Duracon Flat Tibial Wedge Cemented use only Sterile. Tibial Wedge is a component of Total Stabilizer Knee which consists of femoral component, tibial insert, modular offset adaptor, femoral/tibial stem extenders and tibial wedges. Tibial wedges are intended to be used with the Universal tibial baseplate to augment bone loss on the surface of the tibia.
Reason for recall
Stryker Orthopaedics has received two customer complaints regarding Duracon Tibial Wedge implants puncturing the packaging's Tyvek lid(s).
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-0362-2016. 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.