Agency classClass IIOur severity:High FDA (Devices)·Z-1191-2017·Announced 2017-02-22

Encore Medical Recalls LIMA Modular Revision Hip Stems Due to Sterilization Error

Encore Medical is recalling 13 LIMA Modular Revision Hip Stems because they were inadvertently re-sterilized, which may compromise the integrity of the safety screw.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a potential structural defect (compromised safety screw) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Encore Medical, Lp is recalling 13 units of the LIMA Modular Revision Hip Stem, Model 428-01-050_110. The recall is due to an inadvertent re-sterilization of the LIMA Proximal Bodies. The safety screw, which affixes the distal and proximal bodies of the stem, contains a thread-locking plug made from UHMWPE. This material is not approved for repeated gamma sterilization.

The affected devices were distributed nationwide in the United States, specifically in the states of Mississippi, Ohio, Rhode Island, New York, Oklahoma, Texas, California, and Hawaii. The recall involves specific lot codes including 1005528A, 1006882A, 1107305A, and others listed in the agency record.

Healthcare providers and patients should contact Encore Medical, Lp for further instructions regarding the return or replacement of these devices. The source text does not report any illnesses or injuries associated with this recall.

The recalled product

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…
Manufacturer: Encore Medical, Lp
Category: Medical Device — Orthopedic Implant
Hazard: structural-defect
sterilization-error
Affected units: 13

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (17)

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

Distribution

Distributed nationwide across the United States.

The notice also names 8 states specifically:

Same manufacturer · Encore Medical, Lp

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