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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85111

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
March 29, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
PROVIDENCE MEDICAL TECHNOLOGIES

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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
Recall number
Z-2428-2020
Initiated
March 29, 2019
Classification
Class II
Status
Terminated
Quantity
208 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
manufacturing error

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.