Wright Medical Technology, Inc.: CrossCHECK Locking Screw in the following sizes: 3.0 x 8 mm, REF CCP-L3008; 3.0 x 10 mm, REF CCP-L3010; 3.0 x 12 mm, REF CCP-L3012; 3.0 x 14 mm, REF CCP-L3014; 3.0 x 16 mm, REF CCP-L3016; 3.0 x 18 mm, REF CCP-L3018; 3.0 x 20 mm, REF CCP-L3020; 3.0 x 22 mm, REF CCP-L3022; 3.0 x 24 mm, REF CCP-L3024; 3.0 x 26 mm, REF CCP-L3026; 3.0 x 28 mm, REF CCP-L3028; 3.0 x 30 mm, REF CCP-L3030; 3.0 x 32 mm, REF CCP-L3032; 3.0 x 34mm, REF CCP-L3034; 3.0 x 36 mm, REF CCP-L3036; 3.0 x 38 mm, REF CCP-L3038; 3.0 x 40 mm, REF CCP-L3040; 3.5 x 8 mm, REF CCP-L3508; 3.5 x 10 mm, REF CCP-L3510; 3.5 x 12 mm, REF CCP-L3512; 3.5 x 14mm, REF CCP-L3514; 3.5 x 16 mm, REF CCP-L3516; 3.5 x 18 mm, REF CCP-L3518; 3.5 x 20 mm, REF CCP-L3520; 3.5 x 22 mm, REF CCP-L3522; 3.5 x 24 mm, REF CCP-L3524; 3.5 x 26 mm, REF CCP-L3526; 3.5 x 28 mm, REF CCP-L3528; 3.5 x 30 mm, REF CCP-L3530; 3.5 x 35 mm, REF CCP-L3532; 3.5 x 34 mm, REF CCP-L3534; 3.5 x 36 mm, REF CCP-L3536; 3.5 x 38 mm, REF CCP-L3538; 3.5 x 40 mm, REF CCP-L3540 The CROSSCHECK Plating System is indicated for stabilization and fixation of fresh fractures, revision procedures, joint fusion and reconstruction of small bones in the hand, feet wrist and ankles, fingers and toes. The system may be used in both pediatric and adult patients. The device is intended for single use.

Recall number

Z-2541-2015

Recalling firm

Wright Medical Technology, Inc.

Product

CrossCHECK Locking Screw in the following sizes: 3.0 x 8 mm, REF CCP-L3008; 3.0 x 10 mm, REF CCP-L3010; 3.0 x 12 mm, REF CCP-L3012; 3.0 x 14 mm, REF CCP-L3014; 3.0 x 16 mm, REF CCP-L3016; 3.0 x 18 mm, REF CCP-L3018; 3.0 x 20 mm, REF CCP-L3020; 3.0 x 22 mm, REF CCP-L3022; 3.0 x 24 mm, REF CCP-L3024; 3.0 x 26 mm, REF CCP-L3026; 3.0 x 28 mm, REF CCP-L3028; 3.0 x 30 mm, REF CCP-L3030; 3.0 x 32 mm, REF CCP-L3032; 3.0 x 34mm, REF CCP-L3034; 3.0 x 36 mm, REF CCP-L3036; 3.0 x 38 mm, REF CCP-L3038; 3.0 x 40 mm, REF CCP-L3040; 3.5 x 8 mm, REF CCP-L3508; 3.5 x 10 mm, REF CCP-L3510; 3.5 x 12 mm, REF CCP-L3512; 3.5 x 14mm, REF CCP-L3514; 3.5 x 16 mm, REF CCP-L3516; 3.5 x 18 mm, REF CCP-L3518; 3.5 x 20 mm, REF CCP-L3520; 3.5 x 22 mm, REF CCP-L3522; 3.5 x 24 mm, REF CCP-L3524; 3.5 x 26 mm, REF CCP-L3526; 3.5 x 28 mm, REF CCP-L3528; 3.5 x 30 mm, REF CCP-L3530; 3.5 x 35 mm, REF CCP-L3532; 3.5 x 34 mm, REF CCP-L3534; 3.5 x 36 mm, REF CCP-L3536; 3.5 x 38 mm, REF CCP-L3538; 3.5 x 40 mm, REF CCP-L3540 The CROSSCHECK Plating System is indicated for stabilization and fixation of fresh fractures, revision procedures, joint fusion and reconstruction of small bones in the hand, feet wrist and ankles, fingers and toes. The system may be used in both pediatric and adult patients. The device is intended for single use.

Status

Terminated

Initiated

2015-07-21

Posted

2015-09-01

Terminated

2018-08-01

Reason

These screws have a potential of passing through the plate in the case when torque is applied in excessive amounts, which may result in intraoperative malfunction.

Root cause

Employee error

Action

Wright sent an Urgent Medical Device Recall letter dated July 20, 2015, to all affected customers. Customers were asked to complete the attached response form confirming receipt of the notice and the status of any products on hand, and return a copy to Wright by email (complaints@wmt.com or fax (901)867-7401. Also, if customers have any product in their inventory the product should be sent back to Arlington, TN (ALM). For questions regarding this recall call 901-290-5662.

Quantity

107 units

Distribution

Nationwide Distribution

Lot, serial or model codes

CrossCHECK Locking Screw with the following codes: REF CCP-L3008: Lot Number 35000; REF CCP-L3010: Lot Number 35000; REF CCP-L3012: Lot Number 35000-6, 35000; REF CCP-L3014: Lot Number 35000-8, 35000; REF CCP-L3016: Lot Number 35000; REF CCP-L3018: Lot Number 35000; REF CCP-L3020: Lot Number 35000; REF CCP-L3022: Lot Numbers: 35000-16-1, 35000; REF CCP-L3024: Lot Number 35000; REF CCP-L3026: Lot Number 35000; REF CCP-L3028: Lot Number 35000; REF CCP-L3030: Lot Number 35000; REF CCP-L3032: Lot Number 35000; REF CCP-L3034: Lot Number 35000; REF CCP-L3036: Lot Number 35000; REF CCP-L3038: Lot Number 35000; REF CCP-L3040: Lot Number 35000; REF CCP-L3508: Lot Number 35004; REF CCP-L3510: Lot Numbers: 35004-3, 35004; REF CCP-L3512: Lot Numbers: 35004-6, 35004; REF CCP-L3514: Lot Numbers: 35004-7, 35004; REF CCP-L3516: Lot Number 35004; REF CCP-L3518: Lot Numbers: 35004-12, 35004-12-1, 35004; REF CCP-L3520: Lot Numbers: 35004-13, 35004; REF CCP-L3522: Lot Numbers: 35004-16-1, 35004; REF CCP-L3524: Lot Numbers: 35004-18-1, 35004; REF CCP-L3526: Lot Number 35004; REF CCP-L3528: Lot Number 35004; REF CCP-L3530: Lot Number 35004; REF CCP-L3532: Lot Number 35004; REF CCP-L3534: Lot Number 35004; REF CCP-L3536: Lot Number 35004; REF CCP-L3538: Lot Number 35004; REF CCP-L3540: Lot Number 35004

510(k) numbers

["K132594"]

PMA numbers

not on file

Product code

HRS

Firm FEI

3010667733

Firm city

Memphis

Firm state

TN

Firm country

not on file

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

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