FDA Medical Device Recalls (openFDA)
Depuy Orthopaedics, Inc.: S-ROM Distal Femoral Cutting block Guide SZ X- SM/SM, REF 216311001, non-sterile, Depuy International Leeds, England. The product is used to make cuts in the femur to prepare the femur for total knee replacement surgery.
- Recall number
- Z-1388-2011
- Recalling firm
- Depuy Orthopaedics, Inc.
- Product
- S-ROM Distal Femoral Cutting block Guide SZ X- SM/SM, REF 216311001, non-sterile, Depuy International Leeds, England. The product is used to make cuts in the femur to prepare the femur for total knee replacement surgery.
- Status
- Terminated
- Initiated
- 2010-10-19
- Posted
- 2011-02-22
- Terminated
- 2012-12-03
- Reason
- The firm was notified that the Hinge Block Femoral Box Guide cut being off alignment when using the S-ROM Distal Femoral Cutting Block Guide SZ SML/X-SML pin holes to locate. The firm then found that the same issue was found int the MED block size.
- Root cause
- Device Design
- Action
- The firm, DePuy, sent an "URGENT INFORMATION - DEVICE CORRECTION" email and letter dated October 19, 2010 to all customers. The notices described the product, problem and actions to be taken by the customers. The notices stated that: Depuy is issuing a device correction; however, the product may still be used; the devices do not need to be returned; the distributors were to provide a letter to clinicians that were using the device; the surgical technique will be revised in October 2010; the product will undergo a design change, and the recalled product will be traded out in December 2010 and January 2011. If you have any additional questions, please contact DePuy's Scientific Information office at 1-888-554-2482. On 3/4/2011, The firm sent out a revised URGENT DEVICE RECALL asking that all affected cutting guides be taken out of service immediately. Devices should be returned to DePuy and new cutting guides will be sent out within 2 weeks.
- Quantity
- 229
- Distribution
- Worldwide distribution: USA including states of: AZ, AR, CA, CO, FL, GA, IA, ID,IL, IN, KY, KS, LA, MA, MD, MI, MN, NC, NV, PA, TN, TX, VA, WA, and WI; and countries including: Canada and Ireland. Australia, Austria, Canada, Denmark, Ireland, Israel Italy, New Zealand, Russia, Sweden, Switzerland, Spain, and UK.
- Lot, serial or model codes
- C44AJ4000, DG9K94000, DJ5EG4000, DJ5ER4000 and DJ5EW4000.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LXH
- Firm FEI
- 1818910
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28