Z-2965-2018Class II

Peg Fully Threaded, Locking, 2.5mm x 10mm, Item Number 131212610 Orthopedic device used for stabilization and...

Name: Z-2965-2018 Peg Fully Threaded, Locking, 2.5mm x 10mm, Item Number 131212610 Orthopedic device used for stabilization and...
Creator: Zimmer Biomet, Inc.
Published: 2018-07-12
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2018-07-12 / Terminated / root cause: packaging

FDA source

Zimmer Biomet, Inc. began a recall of Peg Fully Threaded, Locking, 2.5mm x 10mm, Item Number 131212610 Orthopedic device used for stabilization and fixation of small bone fragments Intended for... on 2018-07-12. FDA classified it as Class II and gives the reason as "A size 22mm threaded peg was found in the package of a 10mm unit". 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-2965-2018
Classification: Class II
Status: Terminated
Initiated: 2018-07-12
Posted: 2018-08-31
Terminated: 2020-05-01
Recalling firm: Zimmer GmbH
Product: Peg Fully Threaded, Locking, 2.5mm x 10mm, Item Number 131212610 Orthopedic device used for stabilization and fixation of small bone fragments Intended for stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstructions of small bones of the hand, foot, wrist, ankle, humerus, scapula, finger, toe, pelvis and craniomaxillofacial skeleton, particularly in osteopenic bone.
Product code: HRS Plate, Fixation, Bone
Reason for recall: A size 22mm threaded peg was found in the package of a 10mm unit.
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: The firm, Zimmer Biomet, sent an "Urgent Medical Device Recall " letter dated 7/12/18, to customers. The described the product, problem and actions to be taken.The letter instructed Risk Managers to perform the following actions: 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]. Distributors were instructed to perform the following: Your Responsibilities Review this notification and ensure that affected team members are aware of the contents. 1. Immediately locate and quarantine affected product in your inventory. 2. Immediately return all affected product from your distributorship and from affected hospitals within your territory. a. Complete Attachment 1 Inventory Return Certification Form and send to [email protected] within three (3) days. b. Request a Return Authorization Number through [email protected] for international returns c. For each return, send a copy of Att
Quantity in commerce: 25 units
Distribution: International Distribution to countries of: Japan and Netherlands.
Product codes and lots: Lot 969440; UDI (01)00887868012310(17)280309(10)969440

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2965-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2965-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-12	2018-08-31

Product code HRS

K081546Class IISmall Bone Locking Plating SystemDePuy Orthopaedics, Inc. / cleared 2008-08-26

Process control is the most common named cause of a device recall11 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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)