Recall record at a glance
| Official record | Z-0938-2013 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Synthes USA HQ, Inc. |
| Report date | Mar 20, 2013 |
| Recall initiation date | Jan 11, 2013 |
| Quantity | 18 |
| Location | West Chester, PA, United States |
Official product description
Synthes Spine 5.2mm Titanium Click ' X Pedicle Screw Dual Core 40 mm Thread Length, Part Number 487.072. Intended to provide precise and segmental stabilization of the spine in skeletally mature patients.
Why the product was recalled
Lot number 7542279, of the 45 mm Click 'X Pedicle Screw (Part number 487.072), was incorrectly etched as "Click 'X Pedicle Screw 05.2 L40 TAN violet" although the actual length of the screw is 45 mm.
Distribution information
Distributed in the states of AL, CA, MS, MO, NJ, OR, and TN.
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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