Depuy Mitek Fastin RC Anchor with Panacryl (2) strands… recallZ-0446-06 · Depuy Mitek, a Johnson & Johnson Co. · initiated Oct 27, 2005
Terminated All recalls posted in January 2006
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Depuy Mitek, a Johnson & Johnson Co. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The device may contain one strand of suture instead of two strands
FDA root cause category: Other
What the company is doing
DePuy Mitek initiated the recall to domestic accounts by letter on 10/27/05 and to J & J Affiliates by email.
Recall details
- Recall number
- Z-0446-06
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Oct 27, 2005
- Posted by the FDA
- Jan 26, 2006
- Recalling firm
- Depuy Mitek, a Johnson & Johnson Co.
- Quantity
- 19 boxes (5 pieces each)
- Product code
- MAI
- FDA submissions
- K041075
- Distribution
- CA, IA, FL, MI, MO, OR, TX Foreign:Australia, Brazil, Sweden
Product description
Depuy Mitek Fastin RC Anchor with Panacryl (2) strands Size 2 Panacryl Poly ***braided absorbable suture Reference Number: 222740
Code information (models, lots, serial numbers)
Lot Number:1270449
Other devices under the same FDA submission
4 devices cleared under K041075 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- FASTIN ORTHOCORD 222993Medos International Sàrl · Screw, fixation, bone35 reports
- FASTIN ORTHOCORD 222991Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE30 reports
- FASTIN ORTHOCORD 222994Medos International Sàrl · Screw, fixation, bone5 reports
- FASTIN ORTHOCORD 222992Medos International Sàrl · Screw, fixation, bone3 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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