Recall record at a glance
| Official record | Z-0281-2016 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Stryker Howmedica Osteonics Corp. |
| Report date | Nov 25, 2015 |
| Recall initiation date | Oct 15, 2015 |
| Quantity | 1 unit |
| Location | Mahwah, NJ, United States |
Official product description
Stryker PCA 10 Degree Hooded Acetabular Insert ID 22mm, Part of the Howmedica PCA Total Hip System intended for use during total hip arthroplasty. The acetabular insert is used in conjunction with PCA Acetabular Shells and Femoral Heads to restore hip joint biomechanics.
Why the product was recalled
Six (6) PCA 10 Degree Hooded Acetabular Insert-Duration 22 mm (ID) have been distributed in the US, although the 22 mm size was inadvertently omitted from 510(k) #K963612.
Distribution information
Distribution to Virginia only.
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
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