Z-2428-2020Class II

Ally Bone Screw -

Name: Z-2428-2020 Ally Bone Screw -
Creator: Providence Medical Technologies
Published: 2019-03-29
License: https://open.fda.gov/license/

Providence Medical Technology, Inc. / initiated 2019-03-29 / Terminated / root cause: design

FDA source

PROVIDENCE MEDICAL TECHNOLOGIES began a recall of Ally Bone Screw - Product Usage:Bone Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture... on 2019-03-29. FDA classified it as Class II and gives the reason as "There may be dimensional manufacturing error that represents a potential safety risk to patients". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2428-2020
Classification: Class II
Status: Terminated
Initiated: 2019-03-29
Posted: 2020-06-25
Terminated: 2022-05-27
Recalling firm: Providence Medical Technology, Inc.
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.
Product code: HWC Screw, Fixation, Bone
Reason for recall: There may be dimensional manufacturing error that represents a potential safety risk to patients.
Root cause tag: design
FDA root cause: Component design/selection
Action: On 03/29/2019, the firm sent an Customer Notification via email to Sales Representatives and Distributors who were in possession of the affected lots. The Customer Notification informed customers that the firm has determined that there may be non-conformances associated with bone screw and to not use any of the bone screws. Customer are instructed to: -immediately return the affected product, no later than 4/2/2019, and if they have any screws from different lots, these should also be returned. A return FedEx label is included with the email. Customers are also instructed that if the quantities of the product that they have on hand are different from the quantities provided in their email, they are to respond with a thorough explanation of the products whereabouts. Below is a list of potential reasons why the customer may not have the items in their possession. It is necessary to provide a complete accounting of the inventory the Recalling Firm's records show as in their possession. -Used in case and RPO is not yet submitted (provide RPO#) -Gave to (name of person) to support a case in their territory (date of transfer of inventory) -Currently stored at (name of customer) site (these need to be returned as well) -Presently stored at (name of location) (these need to be returned as well) -Returned to HQ on XX/XX/2019 -Converted for emergency demonstration purposes (date of conversion) For any questions, contact the Recalling Firm's Sales Manager or Chief Operating Officer at 415-923-9376
Quantity in commerce: 208 units
Distribution: US Nationwide distribution including in the states of AZ, CA, FL, IL, IN, LA, MA, MO, NC, NJ, NY, OH, OR and TX.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2428-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2428-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-01	2020-06-25

Product code HWC

K121713Class IIPmt Bone ScrewsProvidence Medical Technology, Inc. / cleared 2012-09-27

China's FDA-registered implant bench is 151 establishments of 4,70415 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)