FDA Medical Device Recalls (openFDA)
Encore Medical, LP: 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.
- Recall number
- Z-0135-2021
- 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.
- Status
- Open, Classified
- Initiated
- 2020-09-09
- Posted
- not on file
- Terminated
- not on file
- Reason
- 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
- 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 teffany.hutto@djoglobal.com and/or contact Customer Service at 1-800-456-8696
- Quantity
- 12 cups
- Distribution
- U.S. Nationwide distribution including in the states of CA, MN, MS, NY, SC, TN and VA.
- Lot, serial or model codes
- Model Number: 940-02-54G Lot Number: 801Z1036
- 510(k) numbers
- ["K190057"]
- PMA numbers
- not on file
- Product code
- LPH
- Firm FEI
- 1000116912
- Firm city
- Austin
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28