The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1633-2015·Announced 2015-05-27

Stryker Howmedica Hip Prosthesis Components Recalled for Seal Defects

Stryker Howmedica is recalling 1,147 RESTORATION Acetabular Augment System components because the inner blister seal strength may be below validated requirements, potentially affecting sterile shelf life.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The defect relates to the sterile barrier seal strength, which is a potential risk to sterility but does not involve reported injuries or immediate structural failure.

Plain-English summary

Stryker Howmedica Osteonics Corp. is recalling 1,147 units of the RESTORATION Acetabular Augment System, a sterile hip prosthesis component. The recall is due to a potential defect where the peel strength of the inner blister may have been below internal validated requirements. This seal strength is directly related to the long-term shelf life of the sterile barrier.

The affected products were distributed worldwide, including the United States (nationwide and Puerto Rico), Australia, Canada, China, Brazil, France, Hong Kong, India, Italy, Mexico, Netherlands, Singapore, South Africa, Sweden, and Spain. Specific lot numbers are listed in the recall documentation.

Healthcare providers and patients should check their inventory or medical records for the affected lot numbers. If the product is found, it should be removed from use and returned to the manufacturer or an authorized distributor in accordance with the recall instructions.

The recalled product

Product
Stryker Howmedica Osteonics RESTORATION Acetabular Augment System; Howmedica Osteonics Corp., A subsidiary of Stryker Corporation Made in USA Sterile. Hip prosthesis component. The RESTORATION Acetabular Wedge Augments provide multiple options to address the wide range of…
Manufacturer
Stryker Howmedica Osteonics Corp.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
1,147

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 (12)

  • Ref #:Lot Number - 5096-4615:MMR8M8
  • 5096-4615:MMRLYD
  • 5096-4615:MNAYT7
  • 5096-5015:MMPO6K
  • 5096-5015:MMRWOJ
  • 5096-5015:MNADVA
  • 5096-5815:MNA40L
  • 5096-5820:MMR6HX
  • 5096-5825:MMRLD7
  • 5096-6225:MMPWO5
  • 5096-6225:MMRM2Y
  • 5096-6625:MMNM07

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 3 recalled by Stryker Howmedica Osteonics Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same manufacturer · Stryker Howmedica Osteonics Corp.

See all →

Same hazard · sterility compromise

See all →

Similar recalls