Zimmer Versys Femoral Stem Recall Due to Packaging Adhesion
Zimmer, Inc. is recalling Versys Beaded Fullcoat Femoral Stems because the packaging bag adheres to the polished device surface.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class II, but the specific hazard is a packaging defect (bag adhesion) with no reported injuries or illnesses, fitting the criteria for a Low severity packaging-only problem.
Plain-English summary
Zimmer, Inc. is recalling the Versys Beaded Fullcoat Femoral Stem, a medical device used in total hip replacement surgeries. The recall involves 6,380 units distributed worldwide, including the United States and numerous international markets.
The recall was initiated because the low density polyethylene (LDPE) bag used to package the implants adheres to the highly polished surface of the devices. This packaging defect is the specific reason for the recall action.
Healthcare providers and facilities that have received these devices should stop using them and contact Zimmer, Inc. for further instructions on the recall process.
The recalled product
- Product
- Versys¿ Beaded Fullcoat Femoral Stem (POR FULL-CT FEM ST 11X160MM; VERSYS BEADED FC 11X200MM 8ST; POR FULLCT FEM ST 11 LOW EXT; POR FULLCT FEM ST 11 EXT; POR FLCT FEM STEM LM 11X160MM; POR FULLCT LM FEM ST 11 EXT POR FULL-CT FEM ST 12X160MM VERSYS BEADED FC 12X200MM 8 ST POR…
- Manufacturer
- Zimmer, Inc.
- Hazard
- Affected units
- 6,380
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)
- Part Number Range: 00-7843-011/022-06/56
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 13 recalled by Zimmer, 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.
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