The Recall Desk
ModerateFDA (Devices)·Z-0813-2015·Announced 2014-12-24

Integra LifeSciences Recalls Non-Radiopaque PyroSphere CMC and TMT Implants

Integra LifeSciences is recalling 19 units of PyroSphere CMC and TMT implants because they are non-radiopaque, potentially limiting post-surgical imaging.

What this means for you

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. The hazard is a functional defect (non-radiopacity) that limits diagnostic imaging rather than causing direct physical injury or death, fitting the criteria for a moderate severity recall.

Plain-English summary

Integra LifeSciences Corp. is recalling 19 units of Ascension Orthopedics PyroSphere CMC and PyroSphere TMT devices, size 10, catalogue number PCS-430-10-WW. The affected lots are 140098T and 140929T. These medical devices are intended to replace the joint between the first metacarpal and the trapezium and the 4th/5th tarsometatarsal joint in cases of degenerative or post-traumatic arthritis.

The recall was initiated because a portion of the specific lots are non-radiopaque. Radiopacity allows medical devices to be visible on X-rays; non-radiopaque devices may not be visible during post-surgical imaging, which could complicate medical evaluation or follow-up care.

The affected units were distributed in Washington, Australia, and France. Patients who have had these specific implants should contact their healthcare provider to discuss the recall and determine if further imaging or evaluation is necessary.

The recalled product

Product
Ascension Orthopedics PyroSphere CMC & PyroSphere TMT, intended to replace the joint between the first metacarpal and the trapezium and 4th/5th tarsometatarsal where degenerative of post-traumatic arthritis presents. Size 10; Catalogue No. PCS-430-10-WW
Manufacturer
Integra LifeSciences Corp.
Category
Medical Device — Orthopedic Implants
Hazard
Affected units
19

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)

  • Lot numbers: 140098T and 140929T

Distribution

Distribution scope not specified by the agency.

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