Synthes, Inc.: Medical Device Recall in 2014 - (Recall #: Z-0092-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

DePuy Synthes Radiolucent Retractor, part number 387.580, lot number 3620715

Product Classification:

Class II

Date Initiated: October 2, 2014

Date Posted: October 29, 2014

Recall Number: Z-0092-2015

Event ID: 69432

Reason for Recall:

Particle residue on the instrument from adhesive tape which was used to bind the device during transport. There may be a risk of tissue reaction if a patient is exposed to latex particles from the adhesive tape, or a systemic reaction such as anaphylaxis in patients with latex allergy.

Status: Terminated

Product Quantity: 11

Code Information:

Radiolucent Retractor for Upper Cervical Spine part number 387.580, lot number 3620715.

Distribution Pattern:

US Distribution including the states of PA, NC, TN, NY, WI, WA and MI.

Voluntary or Mandated:

Voluntary: Firm initiated