The Recall Desk
HighFDA (Devices)·Z-2333-2012·Announced 2012-09-19

Aesculap S4 Polyaxial Screws Recalled for Potential Channel Tolerance Defect

Aesculap Implant Systems LLC is recalling S4 Element 4.5mm Polyaxial Screws because the screw channel may be out of tolerance, potentially preventing the screw head from locking to the bone.

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 involves a structural defect in a medical device that could lead to device failure and potential patient harm, but no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Aesculap Implant Systems LLC is recalling Aesculap S4 Element 4.5mm Polyaxial Screws (ST240T, ST241T, ST242T, ST243T, ST244T, and ST245T). The S4 Spinal System is intended for anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation in skeletally mature patients. The recall covers all distributed lots and serial numbers, with nationwide distribution including Illinois, Minnesota, Nevada, Oklahoma, and Texas.

The recall is due to a possibility that the screw channel holding the rod in place may be out of tolerance. If the channel depth is insufficient, the rod may not provide adequate compression on the insert, which can prevent the screw head from locking down to the bone screw.

Healthcare providers and patients should contact Aesculap Implant Systems LLC for further instructions regarding the recall and potential replacement or repair of the devices.

The recalled product

Product
Aesculap S4 Element 4.5mm Polyaxial Screws (ST240T, ST241T, ST242T, ST243T, ST244T, and ST245T). The S4 Spinal System is intended for anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation. Fixation is limited to skeletally mature patients and is i
Manufacturer
Aesculap Implant Systems LLC
Category
Medical Device — Orthopedic / Spinal
Hazard
Affected units
5

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)

  • All distributed lots and serial numbers

Distribution

Distributed nationwide across the United States.

The notice also names 5 states specifically:

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