Recall record at a glance
| Official record | Z-2246-2018 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Synthes (USA) Products LLC |
| Report date | Jun 27, 2018 |
| Recall initiation date | Mar 5, 2018 |
| Quantity | 4 |
| Location | West Chester, PA, United States |
Official product description
Part no. 690.379, Graphic Case F/6.5mm Cannulated Screw Set
Why the product was recalled
Affected screw gauges incorrectly measure screws 5.41mm shorter than the actual overall screw length.
Distribution information
Distributed to accounts in CA, IL, IN, KS, LA, MD, NC, NE, NJ, OR, TX, and VA. Foreign distribution to Canada.
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.
FDA source limitation: openFDA enforcement reports are a reference dataset, not a live public-alert or recall-lifecycle service. FDA notes that enforcement-report status may not be updated after classification. Confirm current actions with the FDA, recalling firm or appropriate healthcare professional when relevant.