Z-0793-2015Class II
PKG, 3MM INSERT, ATRAUMATIC GRASPER, DOUBLE ACTION, 29CM, P/N 0250282101 Laparoscopic Manual Instruments are...
Stryker Corp. / initiated 2014-11-17 / Terminated / root cause: labeling and UDI
Stryker Endoscopy began a recall of PKG, 3MM INSERT, ATRAUMATIC GRASPER, DOUBLE ACTION, 29CM, P/N 0250282101 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and... on . FDA classified it as Class II and gives the reason as "Stryker Endoscopy is recalling Laparoscopic manual instruments and accessories because the parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not...". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.
Recall record
- Recall number
- Z-0793-2015
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Stryker Corp.
- Product
- PKG, 3MM INSERT, ATRAUMATIC GRASPER, DOUBLE ACTION, 29CM, P/N 0250282101 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
- Product code
- KOG
- Reason for recall
- Stryker Endoscopy is recalling Laparoscopic manual instruments and accessories because the parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity cycle and the Ethylene Oxide cycle sterilization methods.
- Root cause tag
- labeling and UDI
- FDA root cause
- Error in labeling
- Action
- Stryker Endoscopy sent an Urgent Device Correction letter dated November 17, 2014, to affected customers. The letter informed the customers of the potential hazards and actions required. Customers were instructed to discard any old Instructions for Use for their Laparoscopic Manual Instruments and Accessories. Download the new Instuctions for Use (IFU1000-401-070 Revision J) from the URL link below: www.stryker.com/IFU1000401070 Customers were instructed to complete and sign the enclosed "Acknowledgement of Receipt" form and email them to [email protected] or fax to (408) 855-6314. Customers with questions were instructed to contact Stryker Endoscopy at 408-855-6238 or via email at [email protected]. For questions regarding this recall call 408-754-2000.
- Quantity in commerce
- 180,573 units total
- Distribution
- Worldwide Distribution - USA (nationwide) and Internationally to Algeria, Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Ecuador, France, Germany, Greece, Guam, Guatemala, India, Italy, Japan, Jordan, Kuwait, Latin America, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Venezuela.
- Product codes and lots
- 344341 645048 747480 844600 845063 845064 940134 941381 1041618 1042438 1042919 1042920 1044110 1044419 1045073 1046405 1144340 1146405 1147034 1241937 1242712 1244995 1342775 1343391 1344025 1344304 1344523 1344871 1344986 1344987 1346214 1346429 1346540 1346683 1440427 1442171 1443413 1443581
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0592-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0593-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0594-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0595-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0596-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0597-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0598-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0599-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0600-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0601-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0602-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0603-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0604-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0605-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0606-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0607-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0608-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0609-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0610-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0611-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0612-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0613-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0614-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0615-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0616-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0617-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0618-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0619-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0620-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0621-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0622-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0623-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0624-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0625-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0626-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0627-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0628-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0629-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0630-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0631-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0632-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0633-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0634-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0635-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0636-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0637-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0638-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0639-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0640-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0641-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0642-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0643-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0644-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0645-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0646-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0647-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0648-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0649-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0650-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0651-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0652-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0653-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0654-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0655-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0656-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0657-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0658-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0659-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0660-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0661-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0662-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0663-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0664-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0665-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0666-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0667-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0668-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0669-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0670-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0671-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0672-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0673-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0674-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0675-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0676-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0677-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0678-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0679-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0680-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0681-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0682-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0683-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0684-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0685-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0686-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0687-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0688-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0689-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0690-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0691-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0692-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0693-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0694-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0695-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0696-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0697-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0698-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0699-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0700-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0701-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0702-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0703-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0704-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0705-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0706-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0707-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0708-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0709-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0710-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0711-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0712-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0713-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0714-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0715-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0716-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0717-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0718-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0719-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0720-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0721-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0722-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0723-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0724-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0725-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0726-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0727-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0728-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0729-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0730-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0731-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0732-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0733-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0734-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0735-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0736-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0737-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0738-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0739-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0740-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0741-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0742-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0743-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0744-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0745-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0746-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0747-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0748-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0749-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0750-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0751-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0752-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0753-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0754-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0755-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0756-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0757-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0758-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0759-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0760-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0761-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0762-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0763-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0764-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0765-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0766-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0767-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0768-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0769-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0770-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0771-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0772-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0773-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0774-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0775-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0776-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0777-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0778-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0779-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0780-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0781-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0782-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0783-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0784-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0785-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0786-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0787-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0788-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0789-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0790-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0791-2015 | Class II | Terminated | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.