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FDA Medical Device Recalls (openFDA)

Stryker Howmedica Osteonics Corp.: Stryker Orthopaedics Tapers LFIT V40 Vitallium femoral heads. hip prosthesis component.

Recall number
Z-0261-2016
Recalling firm
Stryker Howmedica Osteonics Corp.
Product
Stryker Orthopaedics Tapers LFIT V40 Vitallium femoral heads. hip prosthesis component.
Status
Terminated
Initiated
2015-09-08
Posted
2015-11-10
Terminated
2017-07-25
Reason
Complaints that the femoral head could not be assembled with its corresponding V40 stem trunnion at the time of surgery.
Root cause
Process design
Action
Stryker sent an Urgent Medical Device Recall Notifiications dated September 9 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers are asked to complete the attached form and return within 5 days by using email strykerortho6632@stericycle.com or FAX 1-888-965-5803. For further questions please call ( 201) 831-5000.
Quantity
201
Distribution
Nationwide Distribution
Lot, serial or model codes
Catalog Numbers 6260-5-028; 6260-5-032; 6260-5-132; 6260-5-232, 232; 6260-5-328; 6260-5-332; 6260-5-428; 6260-5-432; 6260-9-0928; 6260-9-032, 6260-9-132, 6260-9-232, 6260-9-328, 6260-9-332, 6260-9-428, 6280-0-128, 6280-0-228, 6280-0-232, 6280-0-332  exp- dates july 2019 to august 2019
510(k) numbers
["K121308"]
PMA numbers
not on file
Product code
LPH
Firm FEI
3003070421
Firm city
Mahwah
Firm state
NJ
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.

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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