Z-0135-2021Class II

EMPOWR Acetabular System * EMPOWR Acetabular Cup, Cluster Hole, 54G * Size 54G 54 mm Dia./Cluster Hole...

Name: Z-0135-2021 EMPOWR Acetabular System *** EMPOWR Acetabular Cup, Cluster Hole, 54G *** Size 54G 54 mm Dia./Cluster Hole...
Creator: Encore Medical, LP
Published: 2020-09-09
License: https://open.fda.gov/license/

Encore Medical, LP / initiated 2020-09-09 / Open, Classified / root cause: manufacturing process

FDA source

Encore Medical, LP began a recall of EMPOWR Acetabular System *** EMPOWR Acetabular Cup, Cluster Hole, 54G *** Size 54G 54 mm Dia./Cluster Hole Alpha Code G Liner P2 Porous Coated REF 940-02-54G -... on 2020-09-09. FDA classified it as Class II and gives the reason as "Due to incomplete machining a small peg remnant on the top of the dome that protrudes above the surrounding porous coating causing the cup not to seat properly". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0135-2021
Classification: Class II
Status: Open, Classified
Initiated: 2020-09-09
Posted: 2020-10-20
Recalling firm: Encore Medical, LP
Product: EMPOWR Acetabular System *** EMPOWR Acetabular Cup, Cluster Hole, 54G *** Size 54G 54 mm Dia./Cluster Hole Alpha Code G Liner P2 Porous Coated REF 940-02-54G - Product Usage: are intended for treatment of patients who are candidates for total hip arthroplasty per the indications for use.
Product code: LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Reason for recall: Due to incomplete machining a small peg remnant on the top of the dome that protrudes above the surrounding porous coating causing the cup not to seat properly.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: On 09/11/2020, the firm sent out an email containing an "URGENT FIELD SAFETY NOTICE" to it Surgical/Sales Agents informing them that a product complaint was received stating that a surgeon had issues with implanting the device and stated that "too tight even after reaming line-to-line" and that the affected device did not seat properly. The Recalling Firm was notifying its agents to immediately return all unused affected devices and pointed out that the risks associated with this issue include the following: -Lack of cup fixation -Device loosening -Fracture -Pain -Delay in Surgery -Revision Surgery. Customers were also to perform the following actions by September 25, 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 listed above) using the RMA number. Report any adverse events related to this issue to Customer Service. Additionally, adverse reactions or quality problems experienced with the use of this product may be reported to the FDAs MedWatch Adverse Event Reporting program either online, by regular mail or by fax. For any further questions, contact Teffany Hutto at [email protected] and/or contact Customer Service at 1-800-456-8696
Quantity in commerce: 12 cups
Distribution: U.S. Nationwide distribution including in the states of CA, MN, MS, NY, SC, TN and VA.
Product codes and lots: Model Number: 940-02-54G Lot Number: 801Z1036

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0135-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0135-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-10-28	2020-10-20

Product code LPH

K190057Class IIDJO Acetabular SystemEncore Medical L.P. / cleared 2019-06-07

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)