The Recall Desk
HighFDA (Devices)·Z-1241-2024·Announced 2024-03-13

Synthes Clavicle Plate Implants Recalled Due to Sterility Failure

Synthes is recalling 47 VA-LCP Clavicle Plate 2.7 bone fixation implants (Lot 1201P12) distributed worldwide because sterility cannot be confirmed. Non-sterile surgical implants pose risk of infection.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II recall of an implantable surgical device with confirmed sterility failure, which poses significant risk of surgical site infection. However, no illnesses or injuries have been reported to date. The score reflects the high-risk nature of the defect without confirmed patient harm.

Plain-English summary

Synthes (USA) Products LLC is recalling 47 units of the VA-LCP Clavicle Plate 2.7 implant (Part Number 02.112.621S, Lot 1201P12). These implants are designed to surgically fixate fractured clavicle bone fragments.

The recall was initiated because the products were not sterilized or sterility of the products cannot be confirmed. Surgical implants must be sterile to prevent infection when placed within the patient's body during surgery.

The affected implants were distributed worldwide to surgical facilities in the United States and 19 countries: Argentina, Austria, Australia, Belgium, Canada, Czech Republic, Finland, France, Germany, Ireland, Kuwait, Mexico, Netherlands, Slovakia, South Africa, South Korea, Spain, Taiwan, and the United Kingdom.

Patients who believe they may have received one of these implants should contact their healthcare provider or Synthes directly to determine if their device is affected and to discuss next steps.

The recalled product

Product
VA-LCP Clavicle Plate 2.7, shaft, CS1, right-Intended for fixation of clavicle bone fragments. Part Number: 02.112.621S
Manufacturer
Synthes (USA) Products LLC
Category
Medical Device — Orthopedic Implant
Hazard
  • sterility-failure
  • infection-risk

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 (1)

  • UDI: 10886982279118 Lot Number: 1201P12

Distribution

Distributed nationwide across the United States.

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