Synthes Large Buttress Compression Nut Recalled for Threading Defect
Synthes USA is recalling 135 Large Buttress Compression Nuts for Blade Guide Sleeve TFN because the nuts did not thread completely and became stuck.
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, and the source text describes a functional defect (stuck nut) without reporting any injuries, illnesses, or fatalities, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Synthes USA HQ, Inc. is recalling 135 units of the Large Buttress Compression Nut For Blade Guide Sleeve TFN. This medical device is intended to treat stable and unstable pertrochanteric fractures, intertrochanteric fractures, basal neck fractures, and combinations thereof.
The recall was initiated due to complaints that the compression nut did not thread completely onto the blade guide sleeve and became stuck. The affected units are identified by Part # SD357.371 and specific lot numbers including 5734551, 6083065, 6538811, 6631975, 6703191, 6703190, and 6841538.
The product was distributed in the United States, including the states of Texas, Pennsylvania, New York, Georgia, Colorado, Indiana, American Samoa, Arkansas, Illinois, Michigan, Tennessee, California, Arizona, Mississippi, and Virginia. Healthcare providers should stop using the affected devices and contact Synthes USA HQ, Inc. for further instructions.
The recalled product
- Product
- Large Buttress Compression Nut For Blade Guide Sleeve TFN The Synthes Large Buttress Compression Nut For Blade Guide Sleeve TFN is intended to treat stable and unstable pertrochanteric fractures, intertrochanteric fractures, basal neck fractures, and combinations there of.
- Manufacturer
- Synthes USA HQ, Inc.
- Hazard
- Affected units
- 135
Distribution
Related recalls
Same manufacturer · Synthes USA HQ, Inc.
See all →- ModerateSynthes Electric Pen Drive Hand Switch Recalled for Labeling Error
FDA (Devices) · 2014-01-08
- ModerateSynthes TomoFix Osteotomy System Recalled for Surgical Technique Guide Labeling Error
FDA (Devices) · 2013-12-18
- ModerateSynthes Trochanteric Fixation Nail Recalled for Incorrect Packaging Labeling
FDA (Devices) · 2013-12-18
- SevereSynthes Recalls Titanium Trochanteric Fixation Nail Systems Due to Missing Bend
FDA (Devices) · 2013-12-11
- ModerateSynthes Soft Tissue Retractor Recalled for Locking Nut Malfunction
FDA (Devices) · 2013-12-11
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 ORT300 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
- HighIMRIS ORT200 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
Similar recalls
- ModerateSynthes Titanium Trochanteric Fixation Nail Recall for Non-Conforming Blades
FDA (Devices) · 2013-11-27
- ModerateSynthes Large Combination Clamp Recalled Due to Oversized Hex Nuts
FDA (Devices) · 2013-03-20
- ModerateSynthes Soft Tissue Retractor Recalled for Locking Nut Malfunction
FDA (Devices) · 2013-12-11
- HighSynthes Recalls Five TFN-Advanced Proximal Femoral Nailing Systems
FDA (Devices) · 2015-12-16
- ModerateSynthes Recalls Helical Blade Inserter for TFNA Due to Sizing Defect
FDA (Devices) · 2015-07-22
- SevereSynthes Recalls Titanium Trochanteric Fixation Nail Systems Due to Missing Bend
FDA (Devices) · 2013-12-11