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Biomet® 010001036

by Biomet Orthopedics, Inc.

Biomet® 010001036 is a Class II device made by Biomet Orthopedics, Inc., cleared under FDA 510(k) K121874 on 23 Nov 2012 and listed in FDA GUDID since 24 Oct 2015 (UDI-DI 00880304527836), active as of 23 Oct 2026. 3 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

1 ongoing

This device is named in the recall

Documents

510(k) K121874

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00880304527836 UDI-DI Date24 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK121874 Date23 Nov 2012DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K121874 decided 23 Nov 2012 Active
  • FDA GUDID UDI-DI 00880304527836 listed 24 Oct 2015 Listed

Recalls

3 recalls · 1 ongoing · FDA

    • Ongoing Z-0007-2023 FDA Class II initiated 25 Aug 2022

    The outer sterile package cavity has a corner wall thickness that is below the specification. The thin corner wall could potentially crack during transit. Potential risks include non-clinically or clinically significant extension of surgery, or infection leading to surgical intervention.

  • 2 recalls, same reason

    • Terminated Z-1837-2014 FDA Class II initiated 7 May 2014
    • Terminated Z-1838-2014 FDA Class II initiated 7 May 2014

    Guide rod may fracture during impaction of the acetabular shell and be retained in the inserter or the patient and could result in a delay in surgery.

Timeline

5 dated events

  1. Cleared FDA 510(k) K121874
  2. Recall initiated FDA recalls Z-1837-2014
  3. Recall initiated FDA recalls Z-1838-2014
  4. Listed FDA GUDID 00880304527836
  5. Recall initiated FDA recalls Z-0007-2023

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Biomet®
Generic name
Metallic femoral head prosthesis
Model / Ref / Catalog
010001036
Primary DI / UDI-DI
00880304527836
510(k) Number
FDA product code
JDI, OQG, OQI, LPH, LZO, PBI, OQH, LWZ
GMDN term
Metallic femoral head prosthesis
Device class
Class II
Regulation number
888.3350, 888.3358, 888.3353, 888.3310
GUDID distribution status
In Commercial Distribution

Related devices

Category: Metallic femoral head prosthesis

Cleared under the same submission (K121874)

and 8 more cleared under K121874

Similar devices in this category

Other devices filed under Metallic femoral head prosthesis.

Other devices from Biomet Orthopedics, Inc.

See all devices from Biomet Orthopedics, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (8, all answered No)