Z-1191-2017Class II

LIMA Modular Revision Hip Stem Model 428-01-050_110

Name: Z-1191-2017 LIMA Modular Revision Hip Stem Model 428-01-050_110
Creator: Encore Medical, Lp
Published: 2017-01-10
License: https://open.fda.gov/license/

Encore Medical, LP / initiated 2017-01-10 / Terminated / root cause: manufacturing process

FDA source

Encore Medical, Lp began a recall of LIMA Modular Revision Hip Stem Model 428-01-050_110 Product Usage: The Modular Revision Femoral hip stem is made up of a modular stem coupled with a proper... on 2017-01-10. FDA classified it as Class II and gives the reason as "Lima Proximal Bodies were inadvertently re-sterilized. The safety screw which affixes the distal and proximal bodies of the stem includes a thread-locking plug made from UHMWPE, which is not approved for repeated gamma...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1191-2017
Classification: Class II
Status: Terminated
Initiated: 2017-01-10
Posted: 2017-02-11
Terminated: 2017-03-31
Recalling firm: Encore Medical, LP
Product: LIMA Modular Revision Hip Stem Model 428-01-050_110 Product Usage: The Modular Revision Femoral hip stem is made up of a modular stem coupled with a proper neck by means of a Morse taper stabilized during the implantation phase by a safety screw. This system is particularly indicated for revision surgery on both uncemented and cemented femoral implants, when there is significant bone loss and an abnormal meta-epiphyseal anatomy of the femur.
Product code: KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Reason for recall: Lima Proximal Bodies were inadvertently re-sterilized. The safety screw which affixes the distal and proximal bodies of the stem includes a thread-locking plug made from UHMWPE, which is not approved for repeated gamma sterilization.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: DJO Global sent an Urgent Field Safety Notice letter dated January 10, 2017 to customers. The letter identified the affected product, problem and actions to be taken. Customers were asked to complete the Acknowledgement and receipt Form. Customers were instructed to contact Customer Service at 1-800-456-8696 to explore options for a replacement order.
Quantity in commerce: 13 devices
Distribution: US Nationwide - US Nationwide in the states of MS, OH, RI, NY, OK, TX, CA, HI
Product codes and lots: 1005528A, 1006882A, 1107305A, 1101798A, 1100565A, 1005531A, 1211716A, 1007408A, 1004038B, 1005533D, 1106805A, 1203471A, 1005533C, 1100565A, 1101795A, 1007079A, 1005532A, 1100560A

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1191-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1191-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-22	2017-02-10

Product code KWA

K092331Class IIIDjo Surgical Revision Femoral Hip System, Model 428-14/24-140/200; 428-00-050/110;Encore Medical L.P. / cleared 2010-03-03

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)