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LIMA Modular Revision Hip Stem Model 428-01-050_110 recallZ-1191-2017 · Encore Medical, Lp · initiated Jan 10, 2017

Class II Terminated All recalls posted in February 2017

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Encore Medical, Lp or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Nonconforming Material/Component

What the company is doing

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.

Recall details

Recall number
Z-1191-2017
Recall class
Class II
Status
Terminated
Initiated by the company
Jan 10, 2017
Posted by the FDA
Feb 11, 2017
Recalling firm
Encore Medical, Lp
Quantity
13 devices
Product code
KWA
FDA submissions
K092331
Distribution
US Nationwide - US Nationwide in the states of MS, OH, RI, NY, OK, TX, CA, HI

Product description

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.

Code information (models, lots, serial numbers)

1005528A, 1006882A, 1107305A, 1101798A, 1100565A, 1005531A, 1211716A, 1007408A, 1004038B, 1005533D, 1106805A, 1203471A, 1005533C, 1100565A, 1101795A, 1007079A, 1005532A, 1100560A

Other devices under the same FDA submission

11 devices cleared under K092331 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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