Recall record at a glance
| Official record | Z-1363-2018 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Orthofix, Inc. |
| Report date | Apr 18, 2018 |
| Recall initiation date | Feb 23, 2018 |
| Quantity | 397 units |
| Location | Lewisville, TX, United States |
Official product description
ORTHOFIX, Connector System, SMALL SET SCREW, REF 79-2003
Why the product was recalled
Orthofix is conducting a voluntary recall of the Connector System Large Set Screw (PN: 79-2002) with affected Lot Numbers 001 and 002, and Small Set Screw (PN: 79-2003) with affected Lot Numbers 002, 003 and 004. Through the company's manufacturing controls, size discrepancies were noted with the drive feature for both the large and small sets screws. As a result, it is possible that (1) the set screw drive feature will not accept the Set Screw Driver (PN: 79-1006) or (2) the driver may get wedged in the corners of the drive feature (false bottom) which may lead to a stripped set screw.
Distribution information
US
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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