Alloclassic® Zweymüller® SL 2848

by Zimmer, Inc. 3 variants

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

1 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00889024298279 UDI-DI	Date29 Aug 2016Listed	StatusListed GUDID: in commercial distribution

Recalls

1 recall · FDA

- Terminated Z-0210-2013 FDA Class II initiated 4 Sep 2012
Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 2010 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the info

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: Alloclassic® Zweymüller® SL
Generic Name: Press-fit hip femur prosthesis, modular
Model / Reference: 2848

Primary DI / UDI-DI: 00889024298279
510(k) Number: K030373
FDA Product Code: KWY, KWL, LZO, JDI
GMDN Term: Press-fit hip femur prosthesis, modular

Device Class: Class II
Regulation Number: 888.3390, 888.3360, 888.3353, 888.3350
GUDID distribution status: In Commercial Distribution

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Properties

Sterile
Single Use
Implantable
Prescription Use
Lot / Batch Number
Expiration Date
Manufacturing Date

Other properties (7)

Contains Latex: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Premarket Exempt: No
Serial Number: No