00-5851-071-08

by Zimmer, Inc.

00-5851-071-08 is a Class II device made by Zimmer, Inc., cleared under FDA 510(k) K101296 on 30 Jul 2010 and listed in FDA GUDID since 24 May 2016 (UDI-DI 00889024197282), active as of 23 Oct 2026. 2 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 closed

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00889024197282 UDI-DI	Date24 May 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK101296	Date30 Jul 2010Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00889024197282
FDA 510(k) database 510(k) number K101296

Across registries

2 registries list this device

FDA 510(k) K101296 decided 30 Jul 2010 Active
FDA GUDID UDI-DI 00889024197282 listed 24 May 2016 Listed

Recalls

2 recalls · FDA

- Terminated Z-1381-2018 FDA Class II initiated 29 Mar 2018
There is a potential for debris in the hole on the superior lateral aspect of the device as a result of machining which may not have been adequately removed during the subsequent cleaning process.
- Terminated Z-1219-2015 FDA Class II initiated 5 Feb 2015
PMMA coating does not meet specifications. Area of the stem may be missing PMMA coating.

Timeline

4 dated events

30 Jul 2010 Cleared FDA 510(k) K101296
5 Feb 2015 Recall initiated FDA recalls Z-1219-2015
24 May 2016 Listed FDA GUDID 00889024197282
29 Mar 2018 Recall initiated FDA recalls Z-1381-2018

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Generic name: Orthopaedic prosthesis implantation positioning instrument, reusable
Model / Ref / Catalog: 00-5851-071-08

Primary DI / UDI-DI: 00889024197282
510(k) Number: K101296
FDA product code: LZO, JDI, LPH, KWY
GMDN term: Orthopaedic prosthesis implantation positioning instrument, reusable

Device class: Class II
Regulation number: 888.3353, 888.3350, 888.3358, 888.3390
GUDID distribution status: In Commercial Distribution

Sterilisation method: Moist Heat or Steam Sterilization

Size: Length — 75 Millimeter

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Properties

Sterilise before use
Prescription use
Lot / batch number

Other properties (12, all answered No)