Agency classClass IIOur severity:High FDA (Devices)·Z-1682-2016·Announced 2016-05-25

Zimmer VersaFx Femoral Fixation System Screws Recalled for Sterility Concerns

Zimmer Manufacturing B.V. is recalling specific lots of VersaFx Femoral Fixation System screws because a small hole may be present in the inner tray, potentially compromising sterility.

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 is classified as FDA Class II and involves a potential sterility breach in a medical device, which poses a risk of harm (infection) even though no specific injuries are reported in the source text. This aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Zimmer Manufacturing B.V. is recalling 50 units of the VersaFx Femoral Fixation System Hex head compression screw, 4.7 mm diameter, 2 inch (51 mm) length, catalog number 47116202400. The recall affects lot number 63290189. The product was distributed worldwide, including in the United States, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, the UK, Sweden, and Canada.

The recall was initiated because a small hole may be present in the inner tray of the sterile packaging for these specific lots. This defect could potentially compromise the sterile barrier of the implant screws. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Healthcare providers and facilities that have received this specific lot of the VersaFx Femoral Fixation System screws should stop using the product and contact Zimmer Manufacturing B.V. for instructions on return or replacement. Patients who have already received implants from this lot should contact their healthcare provider for guidance.

The recalled product

Product: VersaFx Femoral Fixation System Hex head compression screw 4.7 mm dia. 2 inch (51 mm) length 47116202400
Manufacturer: Zimmer Manufacturing B.V.
Category: Medical Device — Orthopedic Implants
Hazard: sterility-breach
infection-risk
Affected units: 50

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 (1)

LOT: 63290189

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 12 recalled by Zimmer Manufacturing B.V. 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 12 products in this recall →

Same manufacturer · Zimmer Manufacturing B.V.

See all →

Moderate
Zimmer Recalls Sterile Hip and Trauma Implant Screws Due to Tray Defect
FDA (Devices) · 2016-05-25
Moderate
Zimmer 2.7 mm Cortical Screws Recalled for Potential Tray Hole
FDA (Devices) · 2016-05-25
High
Zimmer Herbert Cannulated Bone Screw Recall for Sterility Concerns
FDA (Devices) · 2016-05-25
High
Zimmer 3.5 mm Cortical Screws Recalled for Potential Sterility Compromise
FDA (Devices) · 2016-05-25
High
Zimmer Manufacturing Recalls Sterile Hip and Trauma Implant Screws
FDA (Devices) · 2016-05-25

Same hazard · sterility breach