Recall record at a glance
| Official record | Z-0197-2023 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Beaver Visitec International, Inc. |
| Report date | Nov 16, 2022 |
| Recall initiation date | Sep 30, 2022 |
| Quantity | 150 units US; 1116 units OUS |
| Location | Waltham, MA, United States |
Official product description
Beaver Arthro-Lok Pointed Tip Curve L 4mm Blade-an orthopedic blade, which may be used in various types of orthopedic surgery (i.e. foot, ankle, hand, knee, hip or spine surgery). Catalog#: 376780
Why the product was recalled
Incorrect configuration of the blades in the package. The blades curve to the right instead of curving to the left. If used may cause cause unintended tissue damage during the procedure or if noticed prior to use may cause a delay in surgery
Distribution information
FL, GA, IN, LA, MA, ME, VA Foreign: France, Japan, Netherlands, Switzerland, 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: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit.
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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