Z-1235-2024Class II

1.5MM Drill Bit/QC/85MM Sterile-surgical, orthopedic, pneumatic powered & accessory/attachment Part Number...

Name: Z-1235-2024 1.5MM Drill Bit/QC/85MM Sterile-surgical, orthopedic, pneumatic powered & accessory/attachment Part Number...
Creator: Synthes (USA) Products LLC
Published: 2024-01-24
License: https://open.fda.gov/license/

Synthes (USA) Products LLC / initiated 2024-01-24 / Open, Classified / root cause: manufacturing process

FDA source

Synthes (USA) Products LLC began a recall of 1.5MM Drill Bit/QC/85MM Sterile-surgical, orthopedic, pneumatic powered & accessory/attachment Part Number: 310.15S on 2024-01-24. FDA classified it as Class II and gives the reason as "Products not sterilized, sterility cannot be confirmed". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1235-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-01-24
Posted: 2024-03-01
Recalling firm: Synthes (USA) Products LLC
Product: 1.5MM Drill Bit/QC/85MM Sterile-surgical, orthopedic, pneumatic powered & accessory/attachment Part Number: 310.15S
Product code: HSZ Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment
Reason for recall: Products not sterilized, sterility cannot be confirmed
Root cause tag: manufacturing process
FDA root cause: Process control
Action: DePuy Synthesis issued Urgent Medical Device Recall (Removal Letter ) via email on 1/24/24. In the US, impacted consignees will be notified via mail, sales consultants and email. OUS Affiliates will be notified via email and will inform their impacted customers per their country regulations and procedures. Letter states reason for recall, health risk and action to take: Steps: 1. Examine your inventory immediately to determine if you have the subject products and quarantine them immediately. DO NOT USE THE SUBJECT PRODUCTS. Ref: 2348044 Page 2 of 3 2. Contact your DePuy Synthes Sales Consultant or contact the customer support services at [email protected] to coordinate the return/credits of the subject products. 3. Review, complete, sign, and return the attached Business Response Form (page 3 of this letter) to [email protected] within three (3) business days of receipt of this notification. Please include in the email subject: FA 2348044. 4. Please complete the attached Business Response Form even if you do not have the subject products on hand. 5. Forward this notice to anyone in your facility that needs to be informed (e.g., those who manage, transport, store, stock, or use the subject products). 6. If any of the subject products have been forwarded to another facility, contact that facility and provide them with this notice. 7. Post a copy of this notice in a visible area for awareness and keep a copy for your records. If you have any questions, please contact your local DePuy Synthes Sales Consultant. For Medical Information request, please visit our website: https://www.jnjmedicaldevices.com/mir
Quantity in commerce: 17 units
Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Austria, Australia, Belgium, Canada, Czech Republic, Germany, Spain, Finland, France, United Kingdom, Ireland, South Korea, Kuwait, Mexico, Netherlands, Slovakia, Taiwan, South Africa.
Product codes and lots: UDI: 10886982186034 Lot Number: 19P4364

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1235-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1234-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-13	2024-03-01
Z-1235-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-13	2024-03-01
Z-1236-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-13	2024-03-01
Z-1237-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-13	2024-03-01
Z-1238-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-13	2024-03-01
Z-1239-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-13	2024-03-01
Z-1240-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-13	2024-03-01
Z-1241-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-13	2024-03-01
Z-1242-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-13	2024-03-01

Product code HSZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

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)