PlainRecalls

Synthes (USA) Products LLC

Compiled from official public sources by the editorial team.

164 recalls on record · Latest: Apr 8, 2026

Synthes (USA) Products LLC Recall Insight

Synthes (USA) Products LLC appears on 164 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.161% of the federal archive, a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Apr 8, 2026, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 14 entries, severity tagging shows 1 critical, 13 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 14 of 14 entries, unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (14). The date window on this page runs from Aug 1, 2012 to Sep 2, 2015.

Manufacturer-level browsing is useful when monitoring a single firm for patterns, whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current, deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement, always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Moderate Sep 2, 2015

Synthes Trauma Ex-Fix System (Small, Medium, Distraction Osteogenesis (DO) and Large) ; (S) intended to stabilize and provide treatment for fractures…

FDA Devices Moderate Sep 2, 2015

Synthes Application Instrument for Sternal ZIPFIX; indications for use include primary or secondary closure/repair of the sternum following sternotom…

FDA Devices Moderate Aug 26, 2015

Synthes Sciatic Nerve Retractor and Sciatic Nerve Retractor Long; Synthes Sciatic Nerve Retractor and Sciatic Nerve Retractor Long are system specifi…

FDA Devices Moderate Aug 26, 2015

Synthes Tibial Nail Wrap Holds 11 Nails and Synthes Intramedullary Nail Wrap Holds 10 Nails; the Nail Wrap is intended to be used as a protective she…

FDA Devices Moderate Aug 19, 2015

8.5mm Reamer Head for Flexible Intramedullary Nailing System; An orthopedic manual surgical instrument is a nonpowered hand-held device intended for …

FDA Devices Moderate Aug 5, 2015

Synthes TI Matrix Pre-Bent Maxillary Plate / 2mm ADVMNT/0.8mm THK/L and Synthes TI Matrix Pre-Bent Maxillary Plate / 2mm ADVMNT/0.8mm THK/R. The Syn…

FDA Devices Moderate Jul 22, 2015

16mm Chisel Blade; used in the LCP Anterior Ankle Arthodesis Plate System and the Hip Preservation Surgery Set. Orthopedic manual surgical instrumen…

FDA Devices Moderate Jul 22, 2015

Helical Blade Inserter for Trochanteric Fixation Nail-ADVANCED (TFNA); intended to secure the head element to the head element inserter to prevent di…

FDA Devices Moderate Jan 14, 2015

Synthes Small Electric Drive (SED), part number: 05.001.175: The Small Electric Drive is designed for use in general traumatology, especially hand an…

FDA Devices Critical Dec 3, 2014

Synthes Titanium Polyaxial Reduction Head for Titanium Matrix Spine Screws: The Titanium Polyaxial Reduction Head is a part of the Matrix Spine Syste…

FDA Devices Moderate Dec 4, 2013

Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar is used as part of the Synthe…

FDA Devices Moderate Dec 4, 2013

Synthes 2.4 mm LC-DCP Plate 6 Holes/51mm Product Usage: Intended for fractures, osteotomies, and replantations of small bones including the foot,…

FDA Devices Moderate Sep 4, 2013

Synthes 2.4mm VA-LCP Two Column Volar Distal Radius Plate and Torque limiting attachment, 1.2Nm Synthes VA-LCP Distal Radius System is intended fo…

FDA Devices Moderate Aug 1, 2012

Universal Spinal System Lamina Hooks Synthes Medium TI Lamina Hook - Right 498.320 Non sterile LOT 6876785 Noncervical spinal fixation device…

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Data Sources

  • Source: FDA + CPSC + NHTSA - federal recall filings naming this firm. Verify with FDA, CPSC, or NHTSA directly.
  • Source: PlainRecalls Manufacturer Index - firm-level aggregation across all three federal recall feeds

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.