The Recall Desk
HighFDA (Devices)·Z-2897-2018·Announced 2018-08-29

Richard Wolf Artholine Punch B 4, 6MM H 1, 6MM Recalled for Potential Injury Risk

Richard Wolf GmbH is recalling 12 units of Artholine Punch B 4, 6MM H 1, 6MM because a potential burr in the joint may increase the risk of injury when the device is opened.

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: The recall is classified as FDA Class II and involves a risk-of-harm product (potential injury from a burr) where no specific injuries or illnesses have been reported in the source text, fitting the criteria for a High severity score.

Plain-English summary

Richard Wolf GmbH is recalling 12 units of the Artholine Punch B 4, 6MM H 1, 6MM. This medical device is used for the removal of soft tissue, cartilage tissue, or other non-osseous tissue via natural or surgically created passages. The specific product number is 89140.0105 and the lot number is 4500197481.

The recall was initiated because the punch may have a burr in one section of the joint. When the punch is open, this defect creates an increased potential for injury. The agency has classified this as a Class II recall.

The affected units were distributed worldwide to Germany, Hong Kong, Ireland, Romania, and Turkey. Healthcare providers and facilities that have received these specific units should stop using them and contact the recalling firm for instructions on return or replacement.

The recalled product

Product
Artholine Punch B 4, 6MM H 1, 6MM, used for the removal of soft tissue, cartilage tissue or other non-osseous tissue via natural or surgically created passages. Product Usage: Device is a standard punch; standard punches are used for the removal of soft tissue, cartilage tis
Manufacturer
Richard Wolf GmbH
Affected units
12

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 (2)

  • Product Number 89140.0105
  • Lot Number 4500197481

Distribution

Distribution scope not specified by the agency.

Same manufacturer · Richard Wolf GmbH

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