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FDA Medical Device Recalls (openFDA)

Wright Medical Technology Inc: Alumina ceramic liner for acetabular shell. This is part of the Transcend ceramic-on-ceramic total hip system.

Recall number
Z-1186-03
Recalling firm
Wright Medical Technology Inc
Product
Alumina ceramic liner for acetabular shell. This is part of the Transcend ceramic-on-ceramic total hip system.
Status
Terminated
Initiated
2003-08-18
Posted
2003-08-28
Terminated
2004-01-29
Reason
Wright Medical commercially distributed Transcend alumina acetabular shell liners lacking the required process validation.
Root cause
Other
Action
Distributors returned thier stock after May 8, 2003
Quantity
133 units
Distribution
nationwide
Lot, serial or model codes
Part No. Lot Serial No. 73003258 070A122950 71002846 101A147607 72003252 101A147579 71002846 01214750 73003258 020A116075 73003258 101A147616 71002846 101A147609 71002846 01214749 72003252 01214581 72003252 01215268 73003258 101A147617 73003258 01214576 74003664 101A147618 72003252 101A147580 71002846 048A080430 72003252 0124580 71002846 01214751 74003664 061A136523 72003252 119A112057 73003258 01214575 71002846 031A139399 72003252 101A147577 72003252 01214582 72003252 101A147578 71002846 039A100609 72003252 081A145884
510(k) numbers
not on file
PMA numbers
not on file
Product code
MRA
Firm FEI
1043534
Firm city
Arlington
Firm state
TN
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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