Z-0634-2022Class II

Universal Chuck-The Universal Chuck is an Instrument Handle provided as an alternative instrument available...

Name: Z-0634-2022 Universal Chuck-The Universal Chuck is an Instrument Handle provided as an alternative instrument available...
Creator: Synthes (USA) Products LLC
Published: 2021-12-22
License: https://open.fda.gov/license/

Synthes (USA) Products LLC / initiated 2021-12-22 / Open, Classified / root cause: design

FDA source

Synthes (USA) Products LLC began a recall of Universal Chuck-The Universal Chuck is an Instrument Handle provided as an alternative instrument available for use in the TN-ADVANCED" Tibial Nailing System... on 2021-12-22. FDA classified it as Class II and gives the reason as "Top cap may loosen and detach if the Universal Chuck becomes jammed and the user attempts to manually free the device, internal ball bearings may fall out onto the surgical field and cause surgical delay or, and if not...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0634-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-12-22
Posted: 2022-02-10
Recalling firm: Synthes (USA) Products LLC
Product: Universal Chuck-The Universal Chuck is an Instrument Handle provided as an alternative instrument available for use in the TN-ADVANCED" Tibial Nailing System (TNA), TFN-ADVANCED" Proximal Femoral Nailing System (TFNA), RFN-ADVANCED" Retrograde Femoral Nailing System (RFNA), FRN-ADVANCED" Femoral Recon Nailing System (FRNA), and Flexible Monobloc Reamers. Instrument Handles are intended for holding instruments for manipulation during orthopedic surgery. Product No.: 03.043.001
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: Top cap may loosen and detach if the Universal Chuck becomes jammed and the user attempts to manually free the device, internal ball bearings may fall out onto the surgical field and cause surgical delay or, and if not recovered, adverse tissue reaction and infection.
Root cause tag: design
FDA root cause: Device Design
Action: Depuy Synthes issued Urgent Medical Device Recall (Removal) issued on 12/22/21 via email FedX. Letter states reason for recall, health risk and action to take: 1. Examine your inventory immediately to determine if you have the subject products and quarantine the subject product. DO NOT USE THE SUBJECT PRODUCT. 2. Contact your DePuy Synthes Sales Consultant or call the customer support services at 1-800-479-6329 to coordinate the return/credits of the subject product. 3. Review, complete, sign, and return the attached Business Response Form (page 3 of this letter) to [email protected] within 3 business days of receipt of this notification. Please include in the email subject: FA 2050712: 2021 Universal Chuck. " Please complete the attached Business Response Form even if you do not have the subject product on hand. 4. Forward this notice to anyone in your facility that needs to be informed (i.e., those who manage, transport, store, stock, or use the subject products). 5. If any of the subject product has been forwarded to another facility, contact that facility and provide them with this notice. 6. Post a copy of this notice in a visible area for awareness and keep a copy for your records. Should you have any inquiries please do not hesitate to contact your DePuy Synthes Sales Consultant. For Medical Information request, please visit our website: https://www.jnjmedicaldevices.com/mir
Quantity in commerce: 600 units
Distribution: US Nationwide distribution.
Product codes and lots: Lot/Serial No.: 20013101, 20052701, 20228901, 20229301, 20253901, 20558602, 20698102, 20777201 21869701, 21983904, 21995301 GTIN: 10886982297372

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0634-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0634-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-02-16	2022-02-10

Product code LXH

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)