Z-0601-2015Class II
PKG, PALPATION PROBE GRADUATED 5MM, P/N 0250080135; Laparoscopic Manual Instruments are intended for cutting...
Stryker Corp. / initiated 2014-11-17 / Terminated / root cause: labeling and UDI
Stryker Endoscopy began a recall of PKG, PALPATION PROBE GRADUATED 5MM, P/N 0250080135; Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue... on . FDA classified it as Class II and gives the reason as "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". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.
Recall record
- Recall number
- Z-0601-2015
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Stryker Corp.
- Product
- PKG, PALPATION PROBE GRADUATED 5MM, P/N 0250080135; 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
- 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
- 11065 12295 36062 38692 38692S 39653 39653Q 40941 41940 45715 47498 48553 53027 57438 59018 61549 65595 67460 68636 69943 71159 71690 72430 73104 73143 76287 78164 81388 82391 83206 84297
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.