Recall record at a glance
| Official record | Z-1019-2019 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | AAP Implantate Ag |
| Report date | Mar 27, 2019 |
| Recall initiation date | Jan 11, 2019 |
| Quantity | 25 units |
| Location | Berlin, N/A, Germany |
Official product description
aap Implante AG, Lambotte chisel, 20 mm, REF IU 3000-20 Product Usage: Surgical instruments are intended to aid in the insertion of bone plates and screws as well as for reduction and support during orthopedic surgeries. If not otherwise specified, instruments are intended for multiple use.
Why the product was recalled
There is the potential for the Lambotte chisel to break at the welded piece parts of the chisel body and knocking plate.
Distribution information
Worldwide Distribution - US Nationwide in the state of Texas and country of Germany
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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