Device recall: PRO-DEX Surgical Driver Battery Pack PDBP-001 Series PRO-DEX Battery Pack, Single Pouch - PDBP-001-2 PRO-DEX Battery…
Class II FDA enforcement event 83113. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Visual particulates within a battery Tyvek pouch. The battery is provided sterile for use with surgical drivers.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Pro-Dex Inc started this device recall on 25 Sep 2018. The firm address in the FDA record is in Irvine, CA. FDA put the recall in Class II. FDA event 83113 has 1 product record. The first FDA enforcement report date is 28 Aug 2019. The record gives the status Terminated, with the termination date 20 Apr 2022.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Worldwide distribution - US Nationwide distributed in the states of CA, FL, MI, and TX, country of Finland.
Recalling firm
Pro-Dex Inc, Irvine, CA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2340-2019 | PRO-DEX Surgical Driver Battery Pack PDBP-001 Series PRO-DEX Battery Pack, Single Pouch - PDBP-001-2 PRO-DEX Battery Pack, 40 Pouches - PDBP-040-2 Product Usage: -The PDBP-001 Battery is a single use (non-rechargeable) sterile lithium ion battery accessory that powers the PDSD Surgical driver. There is only one PDSD… | 68 cases of 40 batteries = 2,720 individual batteries | Class II | Terminated | 28 Aug 2019 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2018
- 1,074
- Share of these events in Class II
- 92%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 5
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 23 Sep 2024 | KLS Martin Battery Pack, REF: KLS BP2 001, and KLS BP2 040 (bulk case of 40), used in conjunction with the KLS Martin Ma | Device | Class II | 1 |
| 15 Feb 2023 | KLS Martin Battery Pack, REF: KLS BP 001, and KLS BP 040 (bulk case of 40), used in conjunction with the KLS Martin MaxD | Device | Class II | 1 |
| 14 Feb 2023 | KLS martin Group KLS E-COUPLING ADAPTER REF PDEC-1000-2 E-Coupling Adapter Assembly used to connect the KLS driver (e.g. | Device | Class II | 1 |
| 23 Dec 2015 | Battery Pack KLS-SD-1000 Case (40 ct) Models: KLS-BP-040 Used to power the KLS Martin Max Driver (battery powdered surgi | Device | Class II | 2 |
Official channels
- FDA enforcement report Z-2340-2019The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 83113. https://recallregister.com/fda/ii/83113/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Worldwide distribution - US Nationwide distributed in the states of CA, FL, MI, and TX, country of Finland.
- What quantity of product is in FDA event 83113?
- The FDA record gives this quantity:
68 cases of 40 batteries = 2,720 individual batteries
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2018 have the same class?
- 92% of the 1,074 device events that started in 2018 are in Class II.