Osteomed, LLC: OSTEOVATIONEX 5CC INJECT FORMULA. REF/UDI: 390-0005/00813845020023 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.

Recall number

Z-2182-2020

Recalling firm

Osteomed, LLC

Product

OSTEOVATIONEX 5CC INJECT FORMULA. REF/UDI: 390-0005/00813845020023 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.

Status

Terminated

Initiated

2020-04-02

Posted

2020-05-29

Terminated

2021-05-05

Reason

Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.

Root cause

Vendor change control

Action

On 04/02/2020, an URGENT Medical Device Recall letter was sent to all consignees affected by the recall. OsteoMed has requested that affected customers: (1) review this letter in full, review current inventory, and complete and return the Acknowledgement and Receipt Form via email or fax; and (2) return unused inventory via Federal Express (using OsteMed account)

Quantity

647

Distribution

Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA. MA, MD, ME. MI, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV and WY and the countries of AUSTRALIA, ITALY, KOREA, MALAYSIA, PERU, SINGAPORE and THAILAND.

Lot, serial or model codes

LOT 1128523, 1129958, 1135746, 1142073, 17071104, 17100404 and 1126669

510(k) numbers

["K051123"]

PMA numbers

not on file

Product code

MQV

Firm FEI

2027754

Firm city

Addison

Firm state

TX

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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