Z-2751-2016Class II

Hard Tissue Replacement (HTR) Implant, Rx only, for use in single procedure only. Custom made. HTR polymer...

Name: Z-2751-2016 Hard Tissue Replacement (HTR) Implant, Rx only, for use in single procedure only. Custom made. HTR polymer...
Creator: Biomet Microfixation, LLC
Published: 2016-06-13
License: https://open.fda.gov/license/

Biomet Microfixation / initiated 2016-06-13 / Terminated / root cause: packaging

FDA source

Biomet Microfixation, LLC began a recall of Hard Tissue Replacement (HTR) Implant, Rx only, for use in single procedure only. Custom made. HTR polymer implants are intended for bone... on 2016-06-13. FDA classified it as Class II and gives the reason as "Potential sterility deficiency". 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-2751-2016
Classification: Class II
Status: Terminated
Initiated: 2016-06-13
Posted: 2016-09-08
Terminated: 2019-08-21
Recalling firm: Biomet Microfixation
Product: Hard Tissue Replacement (HTR) Implant, Rx only, for use in single procedure only. Custom made. HTR polymer implants are intended for bone replacement/augmentation for treatment of craniofacial voids/defects resulting from disease, injury, or surgical trauma.
Product code: KKY Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
Reason for recall: Potential sterility deficiency.
Root cause tag: packaging
FDA root cause: Packaging
Action: Zimmer Biomet Customers were sent an Urgent Product Recall letter dated June 13, 2016, via via FedEx mail. The letter notified customers of a recall of Hard Tissue Replacement Polymer Implants due to voids in sterile packaging. The firm instructed customers to locate and discontinue use of the implants, complete the Fax Response form and fax it to 904-741-9425, send back any quarantined product using the FedEx labels provided along with the recall notification, and to notify facilities where the implant was further distributed by forwarding them a copy of the provided notice. The firm instructed distributors to forward the notice to officials of their customers who are in charge of receiving recall notices. Additionally, the firm informed distributors that they are responsible for locating and returning distributed product. Questions are to be directed to 1-800-874-7711 or 904-741-4400 x9574, Monday thru Friday from 8am to 4pm ET. Her after hours phone is 812-614-9499. For questions regarding this recall call 904-741-9225.
Quantity in commerce: 54 units
Distribution: Worldwide Distribution - US including AZ, CA, FL, MO, NH, PA, TX, & VA, and Internationally to Austria, Canada, England, Germany, Greece, Italy, Netherlands, & South Africa.
Product codes and lots: Custom made, one per customer. Affected units were sealed between April 28, 2016 and June 7, 2016

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2751-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2751-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-14	2016-09-08

Product code KKY

K924935Class IIHard Tissue Replace(htr(r))-Patient-Match ImplantPolyclinic Medical Center / cleared 1993-09-02

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)