| Date Initiated by Firm |
September 25, 2020 |
| Create Date |
November 16, 2020 |
| Recall Status1 |
Open3, Classified |
| Recall Number |
Z-0457-2021 |
| Recall Event ID |
86597 |
| 510(K)Number |
K122113
|
| Product Classification |
Staple, fixation, bone - Product Code JDR
|
| Product |
Osteosynthesis Compression Staple EasyClip |
| Code Information |
All lots of the Osteosynthesis Compression Staple EasyClip and EasyClip Xpress are affected. Exp. Date: 5 years from date of manufacturing EasyClip and EasyClip Xpress staples are available in a variety of sizes identified by product and catalog numbers. See below: Product Number Product Description EZ15-12-12 Osteosynthesis Compression Staple EasyClip 15x12x12mm EZ15-15-15 Osteosynthesis Compression Staple EasyClip 15x15x15mm EZ18-12-12 Osteosynthesis Compression Staple EasyClip 18x12x12mm EZ18-15-13 Osteosynthesis Compression Staple EasyClip 18x15x13mm EZ18-14-14 Osteosynthesis Compression Staple EasyClip 18x14x14mm EZ18-17-15 Osteosynthesis Compression Staple EasyClip 18x17x15mm EZ18-19-17 Osteosynthesis Compression Staple EasyClip 18x19x17mm EZ20-16-16 Osteosynthesis Compression Staple EasyClip 20x16x16mm EZ20-20-20 Osteosynthesis Compression Staple EasyClip 20x20x20mm EZ25-22-22 Osteosynthesis Compression Staple EasyClip 25x22x22mm EZB10-15-13 Osteosynthesis Compression Staple EasyClip 10x15x13mm EZB10-17-15 Osteosynthesis Compression Staple EasyClip 10x17x15mm EZB10-19-16 Osteosynthesis Compression Staple EasyClip 10x19x16mm EZB10-20-17 Osteosynthesis Compression Staple EasyClip 10x20x17mm EZB12-15-13 Osteosynthesis Compression Staple EasyClip 12x15x13mm EZB10-22-20 Osteosynthesis Compression Staple EasyClip 10x22x20mm EZB12-17-15 Osteosynthesis Compression Staple EasyClip 12x17x15mm EZB12-19-16 Osteosynthesis Compression Staple EasyClip 12x19x16mm EZM08-08-08 Osteosynthesis Compression Staple EasyClip 8x8x8mm EZM10-10-10 Osteosynthesis Compression Staple EasyClip 10x10x10mm EZM12-10-10 Osteosynthesis Compression Staple EasyClip 10x10x10mm EZM12-14-14 Osteosynthesis Compression Staple EasyClip 12x14x14mm EZM12-16-16 Osteosynthesis Compression Staple EasyClip 12x16x16mm Catalog # Product EZBXP10-15-13 EasyClip Xpress 10x15x13 EZBXP12-15-13 EasyClip Xpress 12x15x13 EZMXP08-08-08 EasyClip Xpress 08x08x08 EZMXP10-10-10 EasyClip Xpress 10x10x10 EZMXP12-10-10 EasyClip Xpress 12x10x10 EZXP15-12-12 EasyClip Xpress 15x12x12 EZXP15-15-15 EasyClip Xpress 15x15x15 EZXP18-14-14 EasyClip Xpress 18x14x14 EZXP18-17-15 EasyClip Xpress 18x17x15 EZXP18-19-17 EasyClip Xpress 18x19x17 EZXP20-16-16 EasyClip Xpress 20x16x16 EZXP20-20-20 EasyClip Xpress 20x20x20 EZXP25-22-22 EasyClip Xpress 25x22x22 |
Recalling Firm/
Manufacturer |
Stryker GmbH
Bohnackerweg 1
Selzach Switzerland
|
| For Additional Information Contact |
Elizabeth Beato
201-831-5838
|
Manufacturer Reason
for Recall |
The device has the potential to release nickel above the acceptable margin of safety in pediatric patients who weigh less than 20 kg (44.09 lbs) when 2 or more implants are used.
|
FDA Determined
Cause 2 |
Under Investigation by firm |
| Action |
All affected customers were mailed an Urgent Medical Device Correction (UMDC) letter on 09/25/2020 that requested them to take the following actions:
1. Please inform users of this Urgent Medical Device Correction (UMDC) and forward this notice to all individuals who need to be made aware of the recall.
2. Under 21 CFR 803, manufacturers are also required to report any serious injuries where a product has contributed or may have contributed to the event. Please keep Stryker informed of any adverse events associated with this product by emailing soprodexpreports@stryker.com.
3. A response is required, even though you may not have any physical inventory on site anymore.
4. Hospitals/Branches/Agencies: Complete and sign the enclosed Urgent Medical Device Correction Business Reply Form and fax a copy to 1-888-240-4294 or email to StrykerOrtho5568@Stericycle.com.
5. Branches/Agencies Only: Please forward this Urgent Medical Device Correction to the individuals or organizations who have consigned product, if applicable.
Please assist us in meeting our regulatory obligation by faxing back the attached Urgent Medical Device Correction Business Reply Form within 5 days.
We regret any inconvenience this action may cause you and if you have any questions or concerns after reviewing the letter, please contact Customer Service at (201) 831-5000.
For questions pertaining to the recall, email SO_M_PRODUCT_FIELD_ACTION_RESPONSE@stryker.com |
| Quantity in Commerce |
121,517 EasyClip devices and 9,561 EasyClip Xpress devices distributed nationwide in US. |
| Distribution |
The devices were distributed nationwide throughout the US, and to countries OUS.
Easy Clip devices:
As of 09/04/2020, 251,566 EasyClip devices have been manufactured. 121,517 of those devices were distributed to the US, and 102,529 were distributed in countries OUS. 27,520 devices were left in the firm's inventory.
Easy Clip Xpress devices:
As of 09/04/2020, 37,371 EasyClip Xpress devices have been manufactured. 9,561 of those devices were distributed to the US, leaving 27,810 in the firm's inventory. This device is only distributed in the United States. |
| Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
| 510(K) Database |
510(K)s with Product Code = JDR and Original Applicant = STRYKER CORP.
|
