The Recall Desk
HighFDA (Devices)·Z-2429-2023·Announced 2023-08-23

Snowden-Pencer Surgical Dissector Rotation Knob May Crack or Break

Carefusion 2200 Inc is recalling specific lots of the Snowden-Pencer MIS surgical dissector because the rotation knob may crack or break due to a manufacturing defect.

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 surgical device with a structural defect (FDA Class II) that poses a risk of harm, but no injuries, illnesses, or deaths have been reported. Per the severity rubric, recalls involving risk-of-harm products where injury has not yet been reported are scored as High (3).

Plain-English summary

Carefusion 2200 Inc is recalling specific lots of the Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR DIAMOND JAW surgical instrument. The product is a 5-millimeter, 45-centimeter endoscopic surgical dissector with ratcheted design (Reference SP90-7271). Affected lot numbers are B23 and C23, with approximately 20 units distributed to customers in the US and Canada.

The rotation knob on affected units may crack or break due to incorrect use of an adhesive during the manufacturing process. This structural defect could impair device function during surgical procedures.

The recalled product

Product
Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR DIAMOND JAW 5MM, 45CM, RATCHETED, REF SP90-7271; endoscopic surgical device
Manufacturer
Carefusion 2200 Inc
Category
Medical Device — Surgical Instrument
Hazard
  • mechanical-failure
  • structural-defect

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 (3)

  • UDI/DI 10885403161544
  • Lot Numbers: B23
  • C23

Distribution

Distribution scope not specified by the agency.

Related recalls

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