Recall record at a glance
| Official record | Z-2105-2023 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Wright Medical Technology, Inc. |
| Report date | Jul 12, 2023 |
| Recall initiation date | Jun 13, 2023 |
| Quantity | 106 devices |
| Location | Memphis, TN, United States |
Official product description
Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile.
Why the product was recalled
The devices were manufactured with the pin sleeve holes too narrow, which does not allow the pin sleeves to pass through the pin sleeve holes, thereby preventing pin placement through the pin holes.
Distribution information
There was no U.S. distribution, including government and military. Foreign distribution was made to Australia, Belgium, Canada, Chile, China, Colombia, France, Germany, Italy, Mexico, Netherlands, Spain, Sweden, Switzerland, Taiwan, and the United Kingdom.
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: E-Mail.
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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