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Recall Observatory FDA recall evidence

Device product

Ally Bone Screw - Product Usage:Bone Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation appropriate for the size of the device. Screws are intended for single use only. L Providence Medical Technology, Inc. 3875 Hopyard Road, Suite 300, Pleasanton, CA 94588, Rx Only.

Z-2428-2020

March 29, 2019

Class II

Product summary

Firm
PROVIDENCE MEDICAL TECHNOLOGIES
Event
Event 85111
Status
Terminated
Classification
Class II
Quantity
208 units
Official record key
device-enforcement:Z-2428-2020

Official wording

Reason: There may be dimensional manufacturing error that represents a potential safety risk to patients.

Code information: Model Number; PD 32 601 - ALLY Bone Screw L 10mm Lot Number: 046164 Model Number: PD 32 602 - ALLY Bone Screw L 12mm Lot Numbers: 045375 045646 045647 046313

Distribution pattern: US Nationwide distribution including in the states of AZ, CA, FL, IL, IN, LA, MA, MO, NC, NJ, NY, OH, OR and TX.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    manufacturing error