Z-0322-2020Class II

Various Surgical Instruments: Screws and Reamers, Item Nos. 00579104100 00579104200 00579104300 00579104400...

Name: Z-0322-2020 Various Surgical Instruments: Screws and Reamers, Item Nos. 00579104100 00579104200 00579104300 00579104400...
Creator: Zimmer Biomet, Inc.
Published: 2019-10-10
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2019-10-10 / Terminated / root cause: packaging

FDA source

Zimmer Biomet, Inc. began a recall of Various Surgical Instruments: Screws and Reamers, Item Nos. 00579104100 00579104200 00579104300 00579104400 00579105400 00597909526 00597909529 00597909532... on 2019-10-10. FDA classified it as Class II and gives the reason as "Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0322-2020
Classification: Class II
Status: Terminated
Initiated: 2019-10-10
Posted: 2019-11-07
Terminated: 2020-05-19
Recalling firm: Zimmer GmbH
Product: Various Surgical Instruments: Screws and Reamers, Item Nos. 00579104100 00579104200 00579104300 00579104400 00579105400 00597909526 00597909529 00597909532 00597909535 00597909538 00597909541 00597909546 00597909551 00598304027 00598304033 00598304048 00598304148
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Root cause tag: packaging
FDA root cause: Packaging change control
Action: The firm distributed Urgent Medical Device Correction letters to customers on October 10, 2019. The letter informed customers that the previous version of low density polyethylene (LDPE) bag could potentially adhere to the surface of metal devices. Please note, this is separate from the previous recall for highly polished implants packaged in the previous version of the LDPE bags. Customers were asked to take the following actions: 1. Review this notification and ensure that pertinent personnel are aware of the contents. 2. Ensure that backup devices for the affected products are available, as per standard orthopedic procedure planning, to reduce the likelihood of an extension of surgery time. 3. Examine devices thoroughly for adherent LDPE bag residue prior to use. Use a backup device if LDPE bag residue is detected. 4. Return any devices which display adherent LDPE bag residue to Zimmer Biomet, consistent with the standard instructions for use regarding the disposition of damaged components. 5. Complete the Certificate of Acknowledgement and return to the firm. 6. Retain a copy of the acknowledgement form with your field action records in the event of a compliance audit of your facility's documentation. If you have further questions or concerns regarding this recall, please call the firm's customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to [email protected].
Quantity in commerce: 5,459,583 total devices
Distribution: Distributed nationwide.
Product codes and lots: All product manufactured prior to January 2014.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0322-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0298-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-13	2019-11-07
Z-0299-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-13	2019-11-07
Z-0300-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-13	2019-11-07
Z-0301-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-13	2019-11-07
Z-0302-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-13	2019-11-07
Z-0303-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-13	2019-11-07
Z-0304-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-13	2019-11-07
Z-0305-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-13	2019-11-07
Z-0306-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-13	2019-11-07
Z-0307-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-13	2019-11-07
Z-0308-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-13	2019-11-07
Z-0309-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-13	2019-11-07
Z-0310-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-13	2019-11-07
Z-0311-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-13	2019-11-07
Z-0312-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-13	2019-11-07
Z-0313-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-13	2019-11-07
Z-0314-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-13	2019-11-07
Z-0315-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-13	2019-11-07
Z-0316-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-13	2019-11-07
Z-0317-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-13	2019-11-07
Z-0318-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-13	2019-11-07
Z-0319-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-13	2019-11-07
Z-0320-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-13	2019-11-07
Z-0321-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-13	2019-11-07
Z-0322-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-13	2019-11-07
Z-0323-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-13	2019-11-07
Z-0324-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-13	2019-11-07
Z-0325-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-13	2019-11-07
Z-0326-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-13	2019-11-07
Z-0327-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-13	2019-11-07
Z-0328-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-13	2019-11-07
Z-0329-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-13	2019-11-07
Z-0330-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-13	2019-11-07
Z-0331-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-13	2019-11-07
Z-0332-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-13	2019-11-07
Z-0333-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-13	2019-11-07
Z-0334-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-13	2019-11-07
Z-0335-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-13	2019-11-07
Z-0336-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-13	2019-11-07
Z-0337-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-13	2019-11-07
Z-0338-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-13	2019-11-07

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)