Encore Medical Recalls Modified Linear Standard and Lateral Neck Trials
Encore Medical is recalling 14 neck trial sets because a retaining ring component can disassemble from the body of the neck.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 structural failure of a medical device component (retaining ring disassembly) which poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Encore Medical, Lp is recalling 14 units (7 sets) of Modified Linear Standard/Lateral Neck Trials with Spring Sides, reference numbers S-200635 and S-200636. The recall was initiated due to a reported failure where the retaining ring component of a neck trial became disassembled from the body of the neck.
The affected products were distributed to facilities in Colorado, Idaho, and Texas. The specific lot numbers involved are 313R1000, 313R1900, 313R1901, 314R1000, 314R1900, and 314R1901.
Healthcare providers and facilities should stop using the affected neck trials and contact Encore Medical for instructions on return or replacement.
The recalled product
- Product
- MODIFIED LINEAR STANDARD/LATERAL NECK TRIALS WITH SPRING SIDES REF S-200635 and S-200636
- Manufacturer
- Encore Medical, Lp
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)
- Lot: 313R1000
- 313R1900
- 313R1901
- 314R1000
- 314R1900
- 314R1901
Distribution
Related recalls
Same manufacturer · Encore Medical, Lp
See all →- ModerateEMPOWR 3D KNEE insertion instruments recalled for incorrect product size packaging
FDA (Devices) · 2026-07-15
- ModerateEMPOWR 3D Knee surgical device recalled due to packaging discrepancy
FDA (Devices) · 2026-07-15
- SevereKnee and Humeral Socket Implants Recalled for Incorrect Labeling
FDA (Devices) · 2026-03-04
- HighShoulder prosthesis humeral socket inserts recalled over incorrect implant labeling
FDA (Devices) · 2026-03-04
- SevereReverse Shoulder Prosthesis Implants Recalled Over Incorrect Labeling
FDA (Devices) · 2026-03-04
Same hazard · mechanical failure
See all →- SevereCanon Medical Alphenix INFX-8000C/B5 Recalled for Tabletop Shift Risk
FDA (Devices) · 2026-10-14
- ModerateLeMaitre TufTex Over-the-Wire Embolectomy Catheter Recalled for Balloon Failure
FDA (Devices) · 2026-10-14
- HighMirion Captus 4000e Thyroid Uptake System Recalled for Spring Arm Failure
FDA (Devices) · 2026-09-23
- HighIMRIS ORT200 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
- HighIMRIS ORT300 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
Similar recalls
- HighEncore Medical Recalls djosurgical Linear Neck Trials Due to Retaining Ring Failure
FDA (Devices) · 2020-04-22
- ModerateEncore Medical Recalls AltiVate Reverse Humeral Socket Shell Trials
FDA (Devices) · 2018-04-04
- ModerateReverse Shoulder Joint Implant System Recalled for Mislabeling
FDA (Devices) · 2024-01-10
- HighEncore Medical Recalls AltiVate Reverse Humeral Broach Due to Undersized Feature
FDA (Devices) · 2016-01-20
- HighEncore Medical Recalls Foundation Knee System Cut Blocks Due to Marking Error
FDA (Devices) · 2015-08-05
- SevereEncore Medical Recalls Exprt Precision System Hip Implant Components
FDA (Devices) · 2019-04-17