Z-0117-2021Class II

AltiVate Reverse Small Socket Insert, 44mm Semi Constrained - E-Plus, Part Number: 509-03-044 -

Name: Z-0117-2021 AltiVate Reverse Small Socket Insert, 44mm Semi Constrained - E-Plus, Part Number: 509-03-044 -
Creator: Encore Medical, LP
Published: 2020-08-31
License: https://open.fda.gov/license/

Encore Medical, LP / initiated 2020-08-31 / Terminated / root cause: labeling and UDI

FDA source

Encore Medical, LP began a recall of AltiVate Reverse Small Socket Insert, 44mm Semi Constrained - E-Plus, Part Number: 509-03-044 - Product Usage: Per IFU, DJO Surgical shoulder devices are... on 2020-08-31. FDA classified it as Class II and gives the reason as "Product mislabeled. Use may result in a delay in surgery, stopping of surgery, and revision surgery". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0117-2021
Classification: Class II
Status: Terminated
Initiated: 2020-08-31
Posted: 2020-10-16
Terminated: 2024-04-19
Recalling firm: Encore Medical, LP
Product: AltiVate Reverse Small Socket Insert, 44mm Semi Constrained - E-Plus, Part Number: 509-03-044 - Product Usage: Per IFU, DJO Surgical shoulder devices are intended for treatment of patients who are candidates for shoulder arthroplasty per the Indication for use.
Product code: KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Reason for recall: Product mislabeled. Use may result in a delay in surgery, stopping of surgery, and revision surgery.
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: On 08/31/2020, the firm notified affected customers via email using a letter titled, "URGENT FIELD SAFETY NOTICE", indicating the following: The firm requires that you do the following actions by September 11, 2020: 1. This notice needs to be passed on to all those within your organization or to any organization where the potentially affected product has been transferred. 2. Review your stock for the affected products and lot numbers and to quarantine the items until returned. 3. Contact Customer Service at 1-800-456-8696 to place a replacement order and receive an RMA number. You will be provided with a shipping label to return the affected product. 4. Return all affected devices quantities using the RMA number. Your actions above will demonstrate that you have received and understand this notification. If you have any questions, please contact the company's Regulatory Affairs Manager via email. Company telephone number is 1-800-321-9549.
Quantity in commerce: 15
Distribution: US Nationwide distribution.
Product codes and lots: Lot Number: 964W1000

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0117-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0117-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-28	2020-10-16

Product code KWS

K172351Class IIAltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small Hemi-Adapter, AltiVate Reverse, Small Socket InsertEncore Medical L.P. / cleared 2017-10-30

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)