Recall record at a glance
| Official record | Z-0068-2018 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Completed |
| Recalling firm | Limacorporate S.p.A |
| Report date | Nov 15, 2017 |
| Recall initiation date | Sep 8, 2017 |
| Quantity | 20 units in (US) |
| Location | San Daniele del Friuli, N/A, Italy |
Official product description
Delta Cup Beater Positioner - Aligner, model # 9057.20.555 Used during implantation of the Delta Acetabular System
Why the product was recalled
An internal analysis on complaints received indicated that the welding process may have been performed sub optimally in the 12 lot # involved , leading to reduced mechanical strength of the device and possible breakage during impaction when the instrument is subjected to repeated multi-axial stresses.
Distribution information
Worldwide Distribution - US Distribution and to the countries of : Australia, Austria, Belgium, Brazil, Czech Republic, Germany, Italy, New Zealand, Poland, Russia, Slovakia, Slovenia, Spain, South Africa, Switzerland, Turkey, UK and 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: 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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