Z-1257-2018Class II

Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 42mm, REF 804-07-420

Name: Z-1257-2018 Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 42mm, REF 804-07-420
Creator: Encore Medical, Lp
Published: 2018-01-29
License: https://open.fda.gov/license/

Encore Medical, LP / initiated 2018-01-29 / Completed / root cause: design

FDA source

Encore Medical, Lp began a recall of Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 42mm, REF 804-07-420 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder... on 2018-01-29. FDA classified it as Class II and gives the reason as "It was discovered during a surgery that the design of the radius at the base of the pegs of the Anatomic Glenoid Trial (Part Numbers: 804-07-380, 804-07-420, 804-07-460, 804-07-500, and 804-07-540) is much larger on the...". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as design.

Recall record

Recall number: Z-1257-2018
Classification: Class II
Status: Completed
Initiated: 2018-01-29
Posted: 2018-03-28
Recalling firm: Encore Medical, LP
Product: Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 42mm, REF 804-07-420 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction.
Product code: KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Reason for recall: It was discovered during a surgery that the design of the radius at the base of the pegs of the Anatomic Glenoid Trial (Part Numbers: 804-07-380, 804-07-420, 804-07-460, 804-07-500, and 804-07-540) is much larger on the trails than on the implants
Root cause tag: design
FDA root cause: Device Design
Action: DJO Global sent an Urgent Field Safety Notice letter dated January 29, 2018, to affected customers. The letter identified the affected product, problem and actions to be taken. For questions call (512) 834-6255
Quantity in commerce: 92 units
Distribution: US Nationwide Distribution
Product codes and lots: All Serial Numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1257-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1256-2018	Class II	Completed	Voluntary: Firm initiated	2018-04-04	2018-03-28
Z-1257-2018	Class II	Completed	Voluntary: Firm initiated	2018-04-04	2018-03-28
Z-1258-2018	Class II	Completed	Voluntary: Firm initiated	2018-04-04	2018-03-28
Z-1259-2018	Class II	Completed	Voluntary: Firm initiated	2018-04-04	2018-03-28
Z-1260-2018	Class II	Completed	Voluntary: Firm initiated	2018-04-04	2018-03-28

Product code KWS

K162024Class IIAltiVate Anatomic Shoulder SystemEncore Medical L.P. / cleared 2016-11-21

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)