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FDA Medical Device Recalls (openFDA)

Depuy Mitek, a Johnson & Johnson Co.: Depuy Mitek Fastin RC Anchor with Panacryl (2) strands Size 2 Panacryl Poly ***braided absorbable suture Reference Number: 222740

Recall number
Z-0446-06
Recalling firm
Depuy Mitek, a Johnson & Johnson Co.
Product
Depuy Mitek Fastin RC Anchor with Panacryl (2) strands Size 2 Panacryl Poly ***braided absorbable suture Reference Number: 222740
Status
Terminated
Initiated
2005-10-27
Posted
2006-01-26
Terminated
2006-05-02
Reason
The device may contain one strand of suture instead of two strands
Root cause
Other
Action
DePuy Mitek initiated the recall to domestic accounts by letter on 10/27/05 and to J & J Affiliates by email.
Quantity
19 boxes (5 pieces each)
Distribution
CA, IA, FL, MI, MO, OR, TX Foreign:Australia, Brazil, Sweden
Lot, serial or model codes
Lot Number:1270449
510(k) numbers
["K041075"]
PMA numbers
not on file
Product code
MAI
Firm FEI
1221934
Firm city
Raynham
Firm state
MA
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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