PlainRecalls

Synthes (USA) Products LLC

164 recalls on record · Latest: Apr 8, 2026

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Agency notice ledger

Federal filing book Synthes (USA) Products LLC HEAVY-BOOK · SINGLE-AGENCY

#96 of 14,151 · 164 notices · 0.157% archive

  • BOOK 164 notices
  • RANK #96 of 14,151
  • SHARE 0.157% archive
  • AGENCY FDA Devices (164)
  • CAT medical devices
  • CATS 1 category
  • LATEST Apr 8, 2026
  • PHOTO Ford,Lincoln

Nearest notice-volume peer: Ford,Lincoln (1 notice gap)

Synthes (USA) Products LLC accounts for about 0.157% of the 104,423-notice archive on 164 distinct filings — a heavy share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →

Where Synthes (USA) Products LLC sits among 14,151 recalling firms

Synthes (USA) Products LLC ranks 96th of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Synthes (USA) Products LLC vs all firms by recall-notice count

Where this firm's archive sits among every tracked recalling manufacturer

164 96th of 14151 higher than 14,055 of 14,151 firms

Firms, banded by distinct federal recall-event inventory

Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-13

Synthes (USA) Products LLC in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Synthes (USA) Products LLC holds about 0.157% of archive notices alongside 164 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
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 of the small bones, such as the hand, wrist, forearm, foot, and ankle; (M) for the construction of an external fixation frame for the treatment of pediatric and adult fractures; )L) for use to provide treatment for long bone and pelvic fractures that require external fixation; and (DO) for fracture fixation (open and closed),pseudoarthrosis or non-

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 sternotomy or fracture of the sternum to stabilize the sternum and promote fusion

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 specific instruments to the 3.5 mm Low Profile Pelvic System Retractor Set.

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 sheath specifically for Universal Femoral Nails, Universal Tibial Nails, Unreamed Tibial Nail, and the Stainless Steel Tibial Nail during steam sterilization by the hospital.

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 medical purposes to manipulate tissue or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compressio

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 Synthes Matrix ORTHOGNATHIC Fixation System is intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla, mandible and chin in adults and children.

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 instrument.

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 disengagement during head element insertion. Manual orthopedic surgical instrument.

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 and food applications involving surgical procedures such as drilling, burring, reaming, pin and wire placement, cutting of bone and hard tissue.

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 System. Intended for posterior pedicle screw fixation (Tl OS2- ilium), posterior hook fixation (Tl-L5), or anterolateral fixation (T8-L5).

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 Synthes Tibial Nail System EX to stabilize fractures of the proximal and distal tibia and the tibia shaft, open and closed tibia shaft fractures, certain pre- and post- isthmic fractures, and tibial malunions and non-unions.

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, ankle, and hand.

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 for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones.

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 devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Limited to skeletally mature patients with the exception of the small stature USS, which includes small stature and pediatric patients. These devices are indicated as an adjunct to fusion for all of these indications: degenerative disc disease, spond

Synthes (USA) Products LLC carries an outsized archive share

Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.

Frequently Asked Questions

How many federal recall notices name Synthes (USA) Products LLC?
PlainRecalls indexes 164 distinct federal recall events naming Synthes (USA) Products LLC, aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does Synthes (USA) Products LLC sit among other recalling firms?
Synthes (USA) Products LLC ranks #96 of 14,151 by distinct recall-event count among 14,151 firms in this archive (99th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Synthes (USA) Products LLC's notices?
FDA Devices accounts for 164 of this firm's 164 indexed notices.
What product category dominates Synthes (USA) Products LLC's filing book?
Filings for Synthes (USA) Products LLC span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous?
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
Synthes (USA) Products LLC: 164 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.

Firm-level totals aggregate distinct federal recall events naming Synthes (USA) Products LLC; individual notices remain authoritative on each linked recall page.

Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026