FDA Medical Device Recalls (openFDA)
PROVIDENCE MEDICAL TECHNOLOGIES: 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.
- Recall number
- Z-2428-2020
- Recalling firm
- PROVIDENCE MEDICAL TECHNOLOGIES
- 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.
- Status
- Terminated
- Initiated
- 2019-03-29
- Posted
- not on file
- Terminated
- 2022-05-27
- Reason
- There may be dimensional manufacturing error that represents a potential safety risk to patients.
- 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
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K121713"]
- PMA numbers
- not on file
- Product code
- HWC
- Firm FEI
- 3009394448
- Firm city
- Pleasanton
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28