Recall record at a glance
| Official record | Z-1938-2018 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Ad-Tech Medical Instrument Corporation |
| Report date | Jun 6, 2018 |
| Recall initiation date | Dec 20, 2017 |
| Quantity | 30 devices |
| Location | Oak Creek, WI, United States |
Official product description
Disposable Drill Kit which includes two drill bits, two drill stops, and two adjustment wrenches, sterile. The drill bits are 30cm long and made of stainless steel. The drill kits are supplied in a sterile state and are single-use only. Used to drill cranial holes using a stereotactic frame.
Why the product was recalled
There is a possibility that DDK2-2.4-30X Disposable Drill Kits, Lot Number 111664 208140649 contained 2.8mm drill bits from DDK2-2.8-30X Disposable Drill Kits, Lot Number 111745 208140649 and vice versa.
Distribution information
Worldwide Distribution: US (nationwide) to states of: CA, DC, FL, MI, MA, NC, NY, WA, WI; and country of: Canada. Distributed internationally to the United Kingdom.
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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