Recall Z-0657-2009
Ethicon Endo-Surgery Inc · initiated December 9, 2008
Product
Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 34 cm Right Angle Probe (Product Code EPS03)
Codes / lots: Product Code EPS03 - Lot # E4K182, Exp. Date 2012-12; Lot # E4K59R, Exp. Date 2012-12; Lot # E4K67T, Exp. Date 2012-12; Lot # E4K81D, Exp. Date 2012-12; Lot # E4K938, Exp. Date 2012-12; Lot # D4JL20, Exp. Date 2012-09; Lot # D4JL21, Exp. Date 2012-09; Lot # D4JL22, Exp. Date 2012-09; Lot # E4KC1M, Exp. Date 2013-01; Lot # E4KF20, Exp. Date 2013-01; Lot # E4KK23, Exp. Date 2013-02; Lot # E4KK6V, Exp. Date 2013-02; Lot # E4KL0N, Exp. Date 2013-02; Lot # E4KR6Y, Exp. Date 2013-03; Lot # E4KV1X, Exp. Date 2013-03; Lot # E4KX2Z, Exp. Date 2013-03; Lot # E4KY5H, Exp. Date 2013-03; Lot # E4L18A, Exp. Date 2013-04; Lot # E4L404, Exp. Date 2013-04; Lot # E4L66M, Exp. Date 2013-04; Lot # E4L69A, Exp. Date 2013-05; Lot # E4L871, Exp. Date 2013-05; Lot # E4LA7Z, Exp. Date 2013-05; Lot # E4LD0T, Exp. Date 2013-05; Lot # E4LF5F, Exp. Date 2013-05; Lot # E4LJ46, Exp. Date 2013-06; Lot # E4LJ4F, Exp. Date 2013-06; Lot # E4LK9C, Exp. Date 2013-06; Lot # E4LN16, Exp. Date 2013-06; Lot # E4LP57, Exp. Date 2013-07; Lot # E4LR66, Exp. Date 2013-07; Lot # E4LT3Y, Exp. Date 2013-07; Lot # E4LU2Z, Exp. Date 2013-07; Lot # E4LV56, Exp. Date 2013-07; Lot # E4M00W, Exp. Date 2013-08; Lot # E4M01X, Exp.…
Reason for recall
Nickel exposure: The stainless steel tips on the affected product were degrading, causing a small amount of nickel to be released, which may lead to health risks in some patients, particularly those with a known or suspected nickel allergy or sensitivity. Ethicon Endo-Surgery determined the presence of free nickel in the affected product could elicit a reaction in those patients with nickel sens
FDA-determined cause: Process design
Action taken
On 12/9/2008 Ethicon Endo-Surgery sent recall notification letters to their customers instructing them to stop using the product, examine all inventory to determine if they have the affected product on hand and remove the affected products from inventory. They requested that each customer complete the Business Reply Form and fax it back to Stericycle and also return any affected product to Stericycle.
Details
- Recall number
- Z-0657-2009
- Initiated
- December 9, 2008
- Posted by FDA
- January 27, 2009
- Terminated
- October 20, 2010
- Product code
- GCJ – Laparoscope, General & Plastic Surgery
- Quantity
- 48 (labeled as LLC) lots + 4 (labeled as Inc.) lots, totaling 33,654 pieces
- Distribution
- Worldwide distribution: USA, PUERTO RICO, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, CHINA, COLOMBIA, DOMINICAN REPUBLIC, EGYPT, ENGLAND, EQUADOR, GERMANY, GREECE, INDIA, INDONESIA, ISRAEL, ITALY, JAPAN, KOREA, MALAYSIA, MEXICO, PAKISTAN, PANAMA, POLAND, REPUBLIC OF YEMEN, RUSSIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD, TURKEY, UNITED ARAB EMIRATES…
- Recalling firm
- Ethicon Endo-Surgery Inc, Cincinnati, OH
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0655-2009 | Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 34 cm Hook Probe (Product…Nickel exposure: The stainless steel tips on the affected product were degrading, causing a small amount of… | 12/09/2008Terminated |
| Z-0656-2009 | Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 34 cm Spatula Probe (Product…Nickel exposure: The stainless steel tips on the affected product were degrading, causing a small amount of… | 12/09/2008Terminated |
| Z-0658-2009 | Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 34 cm Curved Dissector Probe…Nickel exposure: The stainless steel tips on the affected product were degrading, causing a small amount of… | 12/09/2008Terminated |
| Z-0659-2009 | Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 29 cm Hook Probe (Product…Nickel exposure: The stainless steel tips on the affected product were degrading, causing a small amount of… | 12/09/2008Terminated |
| Z-0660-2009 | Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 29 cm Spatula Probe (Product…Nickel exposure: The stainless steel tips on the affected product were degrading, causing a small amount of… | 12/09/2008Terminated |
| Z-0661-2009 | Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 29 cm Right Angle Probe…Nickel exposure: The stainless steel tips on the affected product were degrading, causing a small amount of… | 12/09/2008Terminated |
| Z-0662-2009 | Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 29 cm Curved Dissector Probe…Nickel exposure: The stainless steel tips on the affected product were degrading, causing a small amount of… | 12/09/2008Terminated |
| Z-0663-2009 | Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 29 cm Needle Probe (Product…Nickel exposure: The stainless steel tips on the affected product were degrading, causing a small amount of… | 12/09/2008Terminated |