Synthes (USA) Products LLC recall records

24 reported ongoing

24 records in this archive. Latest source date Feb 25, 2026.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

FDA device enforcement

DePuy Synthes Hammertoe Continuous Compression Implants, Product No. 46.239.001

The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant included in the sterile kit. If the incorrect drill guide is used, there is potential for bone da...

Class IIReported ongoing

Distribution: US Nationwide distribution.

Official source for DePuy Synthes Hammertoe Continuous Compression Implants, Product No. 46.239.001
FDA device enforcement

Hammertoe Continuous Compression Implant (CCI) Kit Part Number: 46.239.001

Drill Pin (drill bit) is not compatible with the Drill Template included in the kit due to a packaging error, result in a surgical delay and may cause soft tissue damage if a larger incision is required to accommodate an alternative form of fixation. Additi...

Class IIReported ongoing

Distribution: US Nationwide distribution.

Official source for Hammertoe Continuous Compression Implant (CCI) Kit Part Number: 46.239.001
FDA device enforcement

Radial Head Replacement System Implant is a one-piece, stemmed radial head replacement. The radial head is available in diameters of 19, 22 and 25mm. The radial stems range from...

DePuy Synthes Radial Head Replacement System Contraindications added to Electronic Instructions for Use (e-IFU): Absolute contraindications include: Infection, sepsis, osteomyelitis.

Class IIReported ongoing

Distribution: US Nationwide distribution.

Official source for Radial Head Replacement System Implant is a one-piece, stemmed radial head replacement. The radia...
FDA device enforcement

Universal Chuck-The Universal Chuck is an Instrument Handle provided as an alternative instrument available for use in the TN-ADVANCED" Tibial Nailing System (TNA), TFN-ADVANCED...

Top cap may loosen and detach if the Universal Chuck becomes jammed and the user attempts to manually free the device, internal ball bearings may fall out onto the surgical field and cause surgical delay or, and if not recovered, adverse tissue reaction and...

Class IIReported ongoing

Distribution: US Nationwide distribution.

Official source for Universal Chuck-The Universal Chuck is an Instrument Handle provided as an alternative instrument...

Reasons in these listed records

  • The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant included in the sterile kit. If the incorrect drill guide is used, there is potential for bone damage due to incorrec...
  • Drill Pin (drill bit) is not compatible with the Drill Template included in the kit due to a packaging error, result in a surgical delay and may cause soft tissue damage if a larger incision is required to accommodate an alternative form of fixation. Additionally, there is a p...
  • DePuy Synthes Radial Head Replacement System Contraindications added to Electronic Instructions for Use (e-IFU): Absolute contraindications include: Infection, sepsis, osteomyelitis.
  • Top cap may loosen and detach if the Universal Chuck becomes jammed and the user attempts to manually free the device, internal ball bearings may fall out onto the surgical field and cause surgical delay or, and if not recovered, adverse tissue reaction and infection.

These examples come from this result page and are not a ranking of every recall reason.

Checking Synthes (USA) Products LLC

Is there a recall on synthes (usa) products llc right now?

This archive contains 24 records, including 24 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

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Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.

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A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.

What if the search finds no matching record?

This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.

Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

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