Encore Medical Recalls djosurgical Linear Neck Trials Due to Retaining Ring Failure
Encore Medical is recalling 28 djosurgical Linear Neck Trials because the retaining ring has a potential to fail inter-operatively.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a potential mechanical failure (retaining ring) that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Encore Medical, LP is recalling 28 units of djosurgical Linear Neck Trials with Spring Sides. The affected products are nonsterile and include both Standard (REF S-200635) and Lateral (REF S-200636) configurations. The firm name on the label is djosurgical, Austin, TX.
The recall is being issued because the retaining ring on the neck trials has a potential to fail inter-operatively. The specific units involved are all Revision C trials with the following codes: REF S-2000635 (313R1000, 313R1900, 313R1901) and REF S-200636 (314R1000, 314R1900, 314R1901).
Distribution was made to California, Colorado, Maryland, Minnesota, Ohio, Texas, and Washington. There was no foreign, military, or government distribution. Healthcare facilities and consumers should stop using these specific devices and contact Encore Medical for further instructions.
The recalled product
- Product
- 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.
- Manufacturer
- Encore Medical, LP
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- All Revision C trials. REF S-2000635: 313R1000
- 313R1900
- 313R1901
- REF S-200636: 314R1000
- 314R1900
- 314R1901.
Distribution
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