Synthes Material Mix Surgical Instruments Recalled Due to Material Error
Synthes USA is recalling approximately 44 surgical instruments because a material batch was mixed with an incorrect material having lower hardness and corrosion resistance.
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 does not report any hospitalizations, injuries, or illnesses. The hazard is a material defect (lower hardness/corrosion resistance) without reported adverse events, fitting the criteria for a moderate severity score.
Plain-English summary
Synthes USA HQ, Inc. is recalling approximately 44 units of Synthes Material Mix, which includes the Adjustable Cervical Distractor-Right, Matrix Distractor Rack, T-PAL Spacer Remover, and Implant Inserter. These instruments are used in spinal surgery to distract spine segments, distract interbody disc spaces, remove T-PAL spacers, and insert ProDisc implants.
The recall was initiated because one material batch used for the production of these parts was mixed with an incorrect material. This incorrect material has lower hardness and corrosion resistance than specified in the product requirements.
The affected products were distributed nationwide in the United States, including Illinois, Missouri, Texas, and Washington, as well as internationally to Canada and Switzerland. The specific part and lot numbers affected are: part no. 396.396 (lot nos. T989765 and T989780), part no. 03.632.087 (lot T987270), part no. 03.812.005 (lot nos. T987734, T988931, and T987623), and part no. 03.820.129 (lot no. T988206). Healthcare providers should stop using these specific lots and contact Synthes USA for instructions on return or replacement.
The recalled product
- Product
- Synthes Material Mix (Adjustable Cervical Distractor-Right, Matrix Distractor Rack, T-PAL Spacer Remover, Implant Inserter) Synthes Material Mix: Adjustable Cervical Distractor-Right is used to distract spine segment. Matrix Distractor Rack is used to distract the interbody…
- Manufacturer
- Synthes USA HQ, Inc.
- Hazard
- Affected units
- 44
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)
- part no. 396.396 (lot nos. T989765 and T989780)
- part no. 03.632.087 (lotT987270)
- part no. 03.812.005 (lot nos. T987734
- T988931
- and T987623)
- and part no. 03.820.129 (lot no. T988206).
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 · material defect
See all →- HighICU Medical Recalls Plum Administration Sets Due to Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- ModerateParagon 28 Recalls Custom Foot Implant Due to Material Defect
FDA (Devices) · 2026-08-26
- LowParagon 28 Recalls Custom Foot Implant Due to Material Defect
FDA (Devices) · 2026-08-26
- HighNexxZr dental zirconia discs may have reduced or missing dentin layer
FDA (Devices) · 2026-06-17
Similar recalls
- HighSynthes Spine Vectra Adjustable Drill Stop Recalled for Slip Risk
FDA (Devices) · 2013-02-13
- ModerateSynthes VA Implant Rack Recalled for Incorrect Assembly
FDA (Devices) · 2016-12-28
- ModerateSynthes CMF Distraction System Recalled for Misalignment
FDA (Devices) · 2013-07-24
- ModerateSynthes Recalls Matrix Neuro Screwdriver Blades for MR Safety Labeling Errors
FDA (Devices) · 2016-07-20
- ModerateSynthes MIRS Spinal Fixation Devices Recalled for Labeling Correction
FDA (Devices) · 2012-10-10
- ModerateSynthes Recalls Neuro Screwdriver Blades for Incorrect MR Safety Labeling
FDA (Devices) · 2016-07-20