Z-3176-2018Class II

Gentle Thread PLGA Round Head Interference Screw, 7x20mm, Item Number 905612

Name: Z-3176-2018 Gentle Thread PLGA Round Head Interference Screw, 7x20mm, Item Number 905612
Creator: Zimmer Biomet, Inc.
Published: 2018-07-20
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2018-07-20 / Terminated / root cause: manufacturing process

FDA source

Zimmer Biomet, Inc. began a recall of Gentle Thread PLGA Round Head Interference Screw, 7x20mm, Item Number 905612 on 2018-07-20. FDA classified it as Class II and gives the reason as "The Gentle Thread PLGA Round Head, 7x20mm and the Gentle Thread PLGA Full Thread 10x30 have been commingled". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-3176-2018
Classification: Class II
Status: Terminated
Initiated: 2018-07-20
Posted: 2018-09-14
Terminated: 2020-06-04
Recalling firm: Zimmer GmbH
Product: Gentle Thread PLGA Round Head Interference Screw, 7x20mm, Item Number 905612
Product code: HWC Screw, Fixation, Bone
Reason for recall: The Gentle Thread PLGA Round Head, 7x20mm and the Gentle Thread PLGA Full Thread 10x30 have been commingled.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 7/20/18, Urgent Medical Device Recall notification letters were sent to customers. The letters instructed customers to do the following: Risk Managers: 1. Review this notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. Complete Attachment 1 Certificate of Acknowledgement and send to [email protected]. This form must be returned even if you do not have affected products at your facility. 4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation. 5. If you have further questions or concerns after reviewing this notice, please call 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]. Surgeons: 1. Review this notification for awareness of the contents. 2. There are no specific patient monitoring instructions related to this recall that are recommended beyond your existing follow-up schedule. 3. Complete Attachment 1 Certificate of Acknowledgement and send to [email protected]. 4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation. 5. If you have further questions or concerns after reviewing this notice, please call 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 tra
Quantity in commerce: 52
Distribution: The products were distributed to the following US states: IN, TN. The products were distributed to the following foreign countries: Australia, Chile, Netherlands.
Product codes and lots: Lot Number 611330, UDI (1)00880304008526(17)221010(10)611330

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3176-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3176-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-26	2018-09-14
Z-3177-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-26	2018-09-14

Product code HWC

K982497Class IIArthrotek Interference ScrewBiomet, Inc. / cleared 1998-10-16

China's FDA-registered implant bench is 151 establishments of 4,70415 SEP 2026 / by Medical Device Manufacturing

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)