Implantech Recalls Gelzone Shoulder Sleeves Due to Velcro Closure Defect
Implantech Associates Inc is voluntarily recalling Gelzone Shoulder Sleeves because the Velcro closure may not meet robustness requirements.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a functional defect (Velcro robustness) without reporting any injuries, hospitalizations, or specific health hazards, fitting the criteria for a moderate severity voluntary recall.
Plain-English summary
Implantech Associates Inc has initiated a voluntary recall of the Gelzone Shoulder Sleeve, Catalog Number SLV634, Lot Number 852766. The recall involves 300 units of the product, which is used for limb support and/or elevation.
The recall was initiated because the product may not satisfy customer requirements for the robustness of the Velcro closure. The source text does not report any specific injuries or illnesses associated with this defect.
The affected products were distributed nationwide in the United States (specifically in California, Arizona, Illinois, North Carolina, and Colorado) and in South Africa. Consumers should stop using the affected products and contact the recalling firm for further instructions.
The recalled product
- Product
- Gelzone Shoulder Sleeve, Catalog Number SLV634, Lot Number 852766. Product Usage: To be used where limb support and/or elevation is considered necessary.
- Manufacturer
- Implantech Associates Inc
- Hazard
- Affected units
- 300
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 (2)
- Catalog Number SLV634
- Lot Number 852766.
Distribution
Related recalls
Same manufacturer · Implantech Associates Inc
See all →- ModerateImplantech Recalls Terino Square Chin-Style II-Medium Implants
FDA (Devices) · 2013-09-25
Same hazard · functional defect
See all →- ModerateSunMed Tracheal Tube Recalled Due to Suction Catheter Passage Issues
FDA (Devices) · 2026-09-23
- ModerateWilson-Cook Recalls Hemospray Endoscopic Hemostat Due to Adherence Issues
FDA (Devices) · 2026-09-23
- SevereAbiomed Recalls Impella Optical Controllers Due to Purge Sensor Defect
FDA (Devices) · 2026-09-23
- SevereAbiomed Recalls Automated Impella Controllers Due to Purge Sensor Defect
FDA (Devices) · 2026-09-23
- HighMaquet Critical Care Recalls Y Sensor Modules for Electrical Safety Testing Omission
FDA (Devices) · 2026-08-26
Similar recalls
- HighExactech Recalls Equinoxe Reverse Shoulder Compression Screw Kits
FDA (Devices) · 2020-10-07
- ModerateSpineFrontier Recalls S-LIFT Inserter Outer Sleeve Due to Fit Issue
FDA (Devices) · 2013-07-10
- HighExactech Equinoxe Reverse Shoulder Implants Recalled for Nonconforming Packaging
FDA (Devices) · 2024-04-10
- HighUnited Surgical Associates Recalls Elastic Knee Supports for Missing Latex Label
FDA (Devices) · 2015-06-03
- ModerateUnited Surgical Associates Recalls Elastic Ankle Supports for Missing Latex Label
FDA (Devices) · 2015-06-03
- HighTelefac Medical Recalls Weck Facial Closure Systems Due to Detachment Risk
FDA (Devices) · 2016-12-21