Recall record at a glance
| Official record | Z-0362-2016 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Stryker Howmedica Osteonics Corp. |
| Report date | Dec 9, 2015 |
| Recall initiation date | Sep 21, 2015 |
| Quantity | 2,577 units |
| Location | Mahwah, NJ, United States |
Official product description
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.
Why the product was recalled
Stryker Orthopaedics has received two customer complaints regarding Duracon Tibial Wedge implants puncturing the packaging's Tyvek lid(s).
Distribution information
Distributed US (nationwide) and the countries of Australia, Canada, Germany, Hong Kong, Italy, Japan, Malaysia, New Zealand, Netherlands, Poland, Romania, Spain, Sweden and Switzerland.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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