Recall record at a glance
| Official record | Z-1692-2020 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Encore Medical, LP |
| Report date | Apr 22, 2020 |
| Recall initiation date | Jul 10, 2018 |
| Quantity | 28 (14 REF S200635 and 14 S200636) |
| Location | Austin, TX, United States |
Official product description
djosurgical Linear Neck Trials with Spring Sides, Standard, nonsterile, REF S-200635; and djosurgical Linear Neck Trials with Spring Sides, Lateral, nonsterile, REF S-200636. The firm name on the label is djosurgical, Austin, TX.
Why the product was recalled
The retaining ring on the neck trials has a potential to fail interoperatively.
Distribution information
Distribution was made to CA, CO, MD, MN, OH, TX, and WA. There was no foreign/military/government distribution.
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
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