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.
Reported: April 22, 2020 Initiated: July 10, 2018 #Z-1692-2020
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.
Reason for Recall
The retaining ring on the neck trials has a potential to fail interoperatively.
Details
- Recalling Firm
- Encore Medical, LP
- Units Affected
- 28 (14 REF S200635 and 14 S200636)
- Distribution
- Distribution was made to CA, CO, MD, MN, OH, TX, and WA. There was no foreign/military/government distribution.
- Location
- Austin, TX
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Encore Medical, LP. Units affected: 28 (14 REF S200635 and 14 S200636).
Why was this product recalled? ▼
The retaining ring on the neck trials has a potential to fail interoperatively.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 22, 2020. Severity: Moderate. Recall number: Z-1692-2020.
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