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FDA Medical Device Recalls (openFDA)

Aesculap Inc: Metha(R) Hip System Cobalt Chrome (CoCr) Metha Modular Neck Adapters used with the Metha Modular Short Hip Stems. Aesculap AG. Intended to replace a hip joint

Recall number
Z-3014-2011
Recalling firm
Aesculap Inc
Product
Metha(R) Hip System Cobalt Chrome (CoCr) Metha Modular Neck Adapters used with the Metha Modular Short Hip Stems. Aesculap AG. Intended to replace a hip joint
Status
Terminated
Initiated
2011-07-19
Posted
2011-08-12
Terminated
2013-03-19
Reason
Aesculap Implant Systems received a notification from the manufacturer, Aesculap, AG of a fractured CoCr neck adapter.
Root cause
Unknown/Undetermined by firm
Action
AESCULAP Implant Systems sent an "Important Recall Notification" letter dated to all affected customers. The informed customers of a complaint received where fractured CoCR adapter was found and to return any affected product to the firm. The reason for the fracture is currently under investigation. While the firm is trying to determine the root cause of the fracture, they will be offering the Metha non-modular short hip implants to their customers. Customers are asked to return an Inventory Sheet to AESCULAP. For additional information on this recall call (610) 984-9239 or (610) 984-9300.
Quantity
149
Distribution
Nationwide (USA) Distribution including the states of AL, FL, GA, MD, NM, NY, OK, and TN.
Lot, serial or model codes
Part Numbers: NC077K, NC078K, NC079K, NC087K, NC088K, NC089K, NC097K, NC098K, and NC099K)  Lot Numbers: All distributed lot numbers.
510(k) numbers
["K071916"]
PMA numbers
not on file
Product code
LZO
Firm FEI
2916714
Firm city
Center Valley
Firm state
PA
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

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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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