Z-2703-2016Class I

ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA60, SIZE 6 STD; SURFACE POROUS...

Name: Z-2703-2016 ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA60, SIZE 6 STD; SURFACE POROUS...
Creator: MicroPort Orthopedics Inc.
Published: 2016-06-21
License: https://open.fda.gov/license/

Microport Orthopedics Inc. / initiated 2016-06-21 / Terminated

FDA source

MicroPort Orthopedics Inc. began a recall of ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA60, SIZE 6 STD; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 6 FEMUR &... on 2016-06-21. FDA classified it as Class I and gives the reason as "ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2703-2016
Classification: Class I
Status: Terminated
Initiated: 2016-06-21
Posted: 2016-09-08
Terminated: 2017-07-26
Recalling firm: Microport Orthopedics Inc.
Product: ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA60, SIZE 6 STD; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 6 FEMUR & SIZE 6 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total Knee Systems are indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: 1) noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2) inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.
Product code: MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Reason for recall: ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening.
FDA root cause: Use error
Action: MicroPort sent an Urgent Field Safety Notice dated June 22, 2016, to all affected customers. The firm requested customers complete the enclosed form and return by fax 1-901-451-6032 or by email to [email protected]. Customers were also requested to return the affected product. Non-responding consignees will be notified after 30 days. For questions regarding this recall call 901-867-4771.
Quantity in commerce: 38 units
Distribution: Worldwide Distribution only to Australia, Austria, France, Italy, Spain, and United Kingdom
Product codes and lots: all codes

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2703-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2693-2016	Class I	Terminated	Voluntary: Firm initiated	2016-09-14	2016-09-08
Z-2694-2016	Class I	Terminated	Voluntary: Firm initiated	2016-09-14	2016-09-08
Z-2695-2016	Class I	Terminated	Voluntary: Firm initiated	2016-09-14	2016-09-08
Z-2696-2016	Class I	Terminated	Voluntary: Firm initiated	2016-09-14	2016-09-08
Z-2697-2016	Class I	Terminated	Voluntary: Firm initiated	2016-09-14	2016-09-08
Z-2698-2016	Class I	Terminated	Voluntary: Firm initiated	2016-09-14	2016-09-08
Z-2699-2016	Class I	Terminated	Voluntary: Firm initiated	2016-09-14	2016-09-08
Z-2700-2016	Class I	Terminated	Voluntary: Firm initiated	2016-09-14	2016-09-08
Z-2701-2016	Class I	Terminated	Voluntary: Firm initiated	2016-09-14	2016-09-08
Z-2702-2016	Class I	Terminated	Voluntary: Firm initiated	2016-09-14	2016-09-08
Z-2703-2016	Class I	Terminated	Voluntary: Firm initiated	2016-09-14	2016-09-08

Product code MBH

K061223Class IIAdvance Total Knee SystemWrightmedicaltechnologyinc / cleared 2006-08-18

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)