CLASS II Device recall · Reported 1 Jul 2020 · FDA Enforcement Report

Ally Bone Screw recalled by Providence Medical

Providence Medical Technologies is recalling Ally Bone Screw, distributed nationwide in the US. The recall was initiated on 29 Mar 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel 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

Quantity recalled208 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2428-2020
FDA event ID: 85111
Recalling firm: Providence Medical Technologies, Pleasanton, CA
Classification: Class II
Status: Terminated
Recall initiated: 29 Mar 2019
FDA classified: 25 Jun 2020
Reported: 1 Jul 2020
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

29 Mar 2019	Recall initiated by company
25 Jun 2020	Classified by FDA	+454 days
1 Jul 2020	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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.

Where it was distributed

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

Nationwide Arizona California Florida Illinois Indiana Louisiana Massachusetts Missouri North Carolina New Jersey New York Ohio Oregon Texas

Questions about this recall

Is Ally Bone Screw recalled?

Yes. Providence Medical Technologies recalled Ally Bone Screw on 29 Mar 2019. The recall is Class II and its status is Terminated. Recall number Z-2428-2020.

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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