The Recall Desk
HighFDA (Devices)·Z-0722-2018·Announced 2018-03-07

Zimmer Biomet Recalls Versys Hip Prostheses Due to Sterile Barrier Risk

Zimmer Biomet is recalling 38,069 units of Versys 6 inch Beaded Full Coat Plus Hip Prostheses because weight issues may have compromised the sterile barrier.

What this means for you

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 is classified as FDA Class II, and the hazard involves a potential sterile barrier compromise for an implanted medical device, which poses a risk of harm even though specific injuries are not reported in the source text.

Plain-English summary

Zimmer Biomet, Inc. is recalling 38,069 units of the Versys 6 inch Beaded Full Coat Plus Hip Prosthesis. The recall involves various sizes and configurations of the hip prosthesis, including standard and extended neck options, as well as stem components. These devices are intended to replace parts of the femur and tibia in cases requiring extensive resection.

The recall was initiated because the products exceeded the weight previously tested. This condition creates a possibility of damage to the package and/or a compromised sterile barrier. A compromised sterile barrier could potentially affect the sterility of the implant.

The affected products were distributed worldwide, including nationwide in the United States and in numerous international countries such as Canada, Germany, Japan, and Australia. Healthcare providers and patients should contact Zimmer Biomet for further instructions regarding the recall and potential replacement or removal of the devices.

The recalled product

Product
Versys 6 inch Beaded Full Coat Plus Hip Prosthesis. Labeled as follows: a. VERSYS 6 INCH BEADED FC 19X160MM STD BODY STD NECK (Item No. 00894301906); b. VERSYS 6 INCH BEADED FC 21X160MM STD BODY STD NECK (Item No. 00784302106); c. VERSYS 6 INCH BEADED FC 22X160MM STD BO
Manufacturer
Zimmer Biomet, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
38,069

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 (20)

  • a. Item No. 00784301906 (Lot Expiration Date Before 05/31/2025)
  • b. Item No. 00784302106 (Lot Expiration Date Before 06/30/2025)
  • c. Item No. 00784302206 (Lot Expiration Date Before 01/31/2026)
  • d. Item No. 00784301936 (Lot Expiration Date Before 06/30/2026)
  • e. Item No. 00784302036 (Lot Expiration Date Before 01/31/2026)
  • f. Item No. 00784302136 (Lot Expiration Date Before 02/28/2025)
  • g. Item No. 00784302236 (Lot Expiration Date Before 07/31/2026)
  • h.Item No. 00784301406 (Lot Expiration Date Before 07/31/2026)
  • i. Item No. 00784301506 (Lot Expiration Date Before 06/30/2026)
  • j. Item No. 00784301606 (Lot Expiration Date Before 06/30/2026)
  • k. Item No. 00784301706 (Lot Expiration Date Before 06/30/2026)
  • l. Item No. 00784301806 (Lot Expiration Date Before 03/31/2026)
  • m. Item No. 00784301826 (Lot Expiration Date Before 04/30/2026)
  • n. Item No. 00784301926 (Lot Expiration Date Before 11/30/2025)
  • o. Item No. 00784302006 (Lot Expiration Date Before 11/30/2025)
  • p. Item No. 00784302026 (Lot Expiration Date Before 07/31/2026)
  • q. Item No. 00784302126 (Lot Expiration Date Before 07/31/2026)
  • r. Item No. 00784302226 (Lot Expiration Date Before 09/30/2025)
  • s. Item No. 00784301746 (Lot Expiration Date Before 07/31/2026)
  • v. Item No. 00784301846 (Lot Expiration Date Before 07/31/2026)

Distribution

Distributed nationwide across the United States.

The notice also names 48 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Zimmer Biomet, Inc. 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 2 products in this recall →

Related recalls

Same manufacturer · Zimmer Biomet, Inc.

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Same hazard · sterile barrier compromise

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